Resource Library for Medical Device Professionals

240 total results. Use the filters to narrow down the results.

This chart illustrates the steps in the Australia TGA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This video series about the Australia medical device market shows you the process and identifies the key concepts to know before you begin.view all

ビデオ | 16 minutes

This video about the Australia medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

This white paper answers your biggest questions about how to register your medical device or IVD in Australia or New Zealand.view all

記事 | 6 pages

Interested in selling your medical device or IVD in Australia? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Learn about the regulatory structure in Australia and major medical device regulations.view all

 

A brief look at Australia's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

A comprehensive list of medical device regulations in Australia with links to the original documents.view all

規制 | Downloadable PDFs

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

This video about the Brazil medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

This video series about the Brazil medical device market shows you the process and identifies the key concepts to know before you begin.view all

ビデオ | 18 minutes

This chart illustrates the steps in the Brazil ANVISA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This chart illustrates the steps in the Brazil ANVISA IVD approval process and includes a timeline of expected approval.view all

チャート | 2 pages

Thinking about selling your medical device in Brazil? This Brazillian market is complex but the sales potential is worth the effort.view all

記事 | 9 pages

In this white paper, learn about recent changes to the regulatory process for IVDs in Brazil.view all

記事 | 7 pages

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

Interested in selling your medical device or IVD in Brazil? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

A brief look at Brazil's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

Learn about the regulatory structure in Brazil and major medical device regulations.view all

 

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

Learn about the regulatory structure in Canada and major medical device regulations.view all

 

This white paper includes a detailed comparison of Health Canada's Medical Device License application and a US FDA 510(k). view all

記事 | 17 pages

This chart illustrates the steps in the Health Canada medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This chart illustrates the steps in the Health Canada IVD approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This video about the Canada medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

Interested in selling your medical device or IVD in Canada? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

An in-depth look at Quality Management System (QMS) regulations as they apply in Canada for obtaining a Medical Device License (MDL).view all

記事 | 6 pages

A brief look at Canada's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

Learn about the regulatory structure in China and major medical device regulations.view all

 

This chart illustrates the steps in the China CFDA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

Interested in selling your medical device or IVD in China? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

A brief look at China's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

This chart illustrates the steps in the Colombia INVIMA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This video about the Colombia medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

Interested in selling your medical device or IVD in Colombia? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

This chart illustrates the steps in Costa Rica's medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

Interested in selling your medical device or IVD in Costa Rica? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Learn about the regulatory structure in Costa Rica and major medical device regulations.view all

 

A comprehensive list of medical device regulations in Costa Rica with links to the original documents.view all

規制 | Downloadable PDFs

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

This white paper provides an overview of common practices and business customs you should follow to optimize your success entering the Middle East.view all

記事 | 5 pages

Interested in selling your medical device or IVD in Egypt? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

A comprehensive list of medical device regulations in Egypt with links to the original documents.view all

規制 | Downloadable PDFs

Medical device companies selling in Europe are preparing to transition to the new Medical Device Regulation (MDR). The transition deadline seems distant, but there are a lot of factors to consider when coordinating and planning the transition strategyview all

記事 | 10 pages

ISO 13485:2016 provides an international QMS standard and introduces notable changes, particularly in the area of risk management.view all

記事 | 16 pages

Europe's new Medical Device Regulation (MDR) will bring substantial changes to the medical device industry. How will this affect your company?view all

記事 | 14 pages

Europe's new In Vitro Diagnostic Regulation (IVDR) will bring significant regulatory changes for IVD manufacturers selling in Europe.view all

記事 | 16 pages

This chart illustrates the steps in Europe's medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This chart illustrates the steps in Europe's IVD approval process and includes a timeline of expected approval.view all

チャート | 2 pages

In this webinar we will tell you how to deal with the issue of transitioning to another Notified Body and/or how to evaluate your options in establishing a new relationship.view all

ビデオ | 1 hour live webinar

In this recorded webinar we cover the major changes that have been made and tell you what needs to be done before you seek recertification by your Notified Body.view all

ビデオ | 1 hour live webinar

Risk management requirements for medical device manufacturers will expand significantly with the publication of ISO 13485:2016. Manufacturers will have to approach risk management controls in a new way, and change how they integrate it with their quality view all

ビデオ | 1 hour webinar

A comprehensive list of medical device regulations in Europe with links to the original documents.view all

規制 | Downloadable PDFs

In this 35 minute recorded webinar from September 2016, we outline the most important MDR changes you need to know about.view all

ビデオ | 35 min

In this paper, we answer your biggest questions about the obstacles and opportunities of marketing companion diagnostics in the US and Europe.view all

記事 | 5 pages

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

Take a deep dive into the key elements of an EU Technical File, including preparation, formatting, and common elements.view all

記事 | 8 pages

A brief look at Europe's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

Post-market surveillance is a regulatory requirement the US and Europe and helps you ensure your device's safety and effectiveness.view all

記事 | 6 pages

This white paper explores risk management procedures and protocols required to comply with ISO 14971.view all

記事 | 9 pages

In this video, learn more about the background of EN ISO 13485, and the steps you can take to obtain ISO 13485 certification in Europe.view all

ビデオ | 29 minutes

This video about the European medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

Within the next few years, the regulatory landscape will change dramatically for IVD companies selling in Europe. The IVDR will be an entirely new classification scheme for IVDS, and places far more emphasis on clinical data and risk management view all

ビデオ | 1 hour

This video explores CERs, including what they are, why you need one, the research process, and contents and formatting.view all

ビデオ | 4 minutes

Your conformity assessment route has implications for your business you might not expect. How do you know which route is best for you?view all

記事 | 6 pages

If you are marketing a device in Europe, the US, or even beyond, the ISO 10993 series is your guide to biocompatibility testing requirements.view all

記事 | 16 pages

A brief look at Germany's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

How do you classify a product that fits the definition of two or more product types? This paper explains borderline classification in the EU.view all

記事 | 5 pages

This video series about the European medical device market shows you the process and identifies the key concepts to know before you begin.view all

ビデオ | 21 minutes

A brief look at Ireland's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

Learn about the standards, requirements, and benefits of medical device labeling and symbols. Includes a list of common symbols and meanings.view all

記事 | 7 pages

A brief look at Italy's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

A brief look at The Netherlands' medical device market, including potential opportunities and obstacles for manufacturers.view all

 

Vigilance reporting is confusing for many manufacturers in Europe but it is critical to comply with vigilance requirements. view all

記事 | 5 pages

This white paper discusses key points of the Notified Body search, including how to find a new Notified Body well-suited to your company.view all

記事 | 5 pages

A brief look at Poland's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

This white paper discusses the European clinical investigation requirements and how to know when you're ready for this important step.view all

記事 | 5 pages

ISO 11135:2014 is recognized as the international standard for process management and validation requirements of Ethylene Oxide (EO) sterilization.view all

記事 | 12 pages

A brief look at Spain's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

The clinical evaluation report (CER) is a key component of Technical File and the CE Marking process so it's important to get it right.view all

記事 | 4 pages

Interested in selling your medical device or IVD in Europe? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

CE Marking is required to sell your medical device in Europe. Get an overview of the process, requirements, regulations, and more.view all

記事 | 8 pages

A brief look at Sweden's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

What if you have two medical devices that are combined and used together? Learn how Europe regulates device systems.view all

記事 | 3 pages

Learn about the regulatory structure in France and major medical device regulations.view all

 

How to avoid errors in communication, planning, conduct, evaluation, or reporting of clinical studies that could delay your market access in Europe.view all

記事 | 5 pages

A brief look at Switzerland's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

Learn about the regulatory structure in Italy and major medical device regulations.view all

 

A brief look at Belgium's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

A brief look at the United Kingdom's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

Learn about the regulatory structure in Spain and major medical device regulations.view all

 

A brief look at the Czech Republic's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

Medical device suppliers and subcontractors are subject to on-site unnanounced Notified Body audits. Learn how to stay in compliance.view all

記事 | 4 pages

In this white paper, we discuss audit and assessment duties for Notified Bodies in Europe, including performing unannounced audits.view all

記事 | 8 pages

Learn about the regulatory structure in The Netherlands and major medical device regulations.view all

 

A brief look at France's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

In this video, learn about medical device labeling symbols, their meanings, and how they communicate important product information.view all

ビデオ | 11 min

Learn about the regulatory structure in Germany and major medical device regulations.view all

 

This chart illustrates the steps in the Hong Kong MDCO medical device approval process and includes a timeline of expected approval.view all

チャート | 1 page

Interested in selling your medical device or IVD in Hong Kong? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

This chart illustrates the steps in India's medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This video about India's medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

Interested in selling your medical device or IVD in India? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Learn about the regulatory structure in India and major medical device regulations.view all

 

A comprehensive list of medical device regulations in India with links to the original documents.view all

規制 | Downloadable PDFs

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

A brief look at India's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

Interested in selling your medical device or IVD in Israel? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

In this white paper, we discuss quality system assessment under Japan's new regulation, the Pharmaceutical and Medical Device Act.view all

記事 | 8 pages

This video series about Japan's medical device market shows you the process and identifies the key concepts to know before you begin.view all

ビデオ | 17 minutes

In this white paper, we discuss how to register a medical device for sale in Japan as a foreign company and requirements to be aware of.view all

記事 | 6 pages

This chart illustrates the steps in Japan's PMDA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This video about Japan's medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

Interested in selling your medical device or IVD in Japan? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

Learn about the most complex aspects of the Japanese medical device registration process from EMERGO's VP of Business Development.view all

ビデオ | 47 min

Determining the Japanese clinical data requirements for your device can be challenging. This paper explains PMDA clinical requirements.view all

記事 | 8 pages

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

Learn about the regulatory structure in Japan and major medical device regulations.view all

 

A brief look at Japan's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

A comprehensive list of medical device regulations in Japan with links to the original documents.view all

規制 | Downloadable PDFs

This video about Mexico's medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

Learn about medical device and IVD regulations and registration requirements in this white paper. view all

記事 | 6 pages

This chart illustrates the steps in Malaysia's MDA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

Interested in selling your medical device or IVD in Malaysia? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

A comprehensive list of medical device regulations in Malaysia with links to the original documents.view all

規制 | Downloadable PDFs

Learn about the regulatory structure in Malaysia and major medical device regulations.view all

 

Learn about the regulatory structure in Mexico and major medical device regulations.view all

 

This video series about Mexico's medical device market shows you the process and identifies the key concepts to know before you begin.view all

ビデオ | 16 minutes

This chart illustrates the steps in Mexico's medical device and IVD approval process and includes a timeline of expected approval.view all

チャート | 2 page chart

This video about Mexico's medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

This white paper discusses the advantages and disadvantages to consider when choosinig a medical device registration route in Mexico.view all

記事 | 10 pages

Interested in selling your medical device or IVD in Mexico? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Mexico's importation process is challenging. This white paper explores how to successfully import medical devices to Mexico.view all

記事 | 7 pages

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

A brief look at Mexico's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

Interested in selling your medical device or IVD in New Zealand? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

This white paper answers your biggest questions about how to register your medical device or IVD in Australia or New Zealand.view all

記事 | 6 pages

Learn about the regulatory structure in New Zealand and major medical device regulations.view all

 

A comprehensive list of medical device regulations in Peru with links to the original documents.view all

規制 | Downloadable PDFs

This chart illustrates the steps in Russia's medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

Interested in selling your medical device or IVD in Russia? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

This white paper discusses the regulatory landscape in Russia, challenges manufacturers might face, and changes expected to be introduced.view all

記事 | 7 pages

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

A brief look at Russia's medical device market, including potential opportunities and obstacles for manufacturers.view all

 

This chart illustrates the steps in Saudi Arabia's SFDA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This video about Saudi Arabia's medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

Interested in selling your medical device or IVD in Saudi Arabia? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

This white paper provides an overview of common practices and business customs you should follow to optimize your success entering the Middle East.view all

記事 | 5 pages

An overview of the medical device regulatory system in Saudi Arabia, including the history, framework, and registration process.view all

記事 | 9 pages

The Secretariat-General for Health Tender is a cross-border tender system that provides a predictable process for purchasing medical devices.view all

記事 | 4 pages

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

Learn about the regulatory structure in Saudi Arabia and major medical device regulations.view all

 

Learn about medical device regulations in Singapore, including classification, registration routes, submission requirements, and more.view all

記事 | 6 pages

This video about Singapore's medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

This chart illustrates the steps in Singapore's HSA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

Interested in selling your medical device or IVD in Singapore? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Learn about the regulatory structure in Singapore and major medical device regulations.view all

 

Interested in selling your medical device or IVD in South Africa? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Learn about the regulatory structure in South Africa and major medical device regulations.view all

 

This video series about South Korea's medical device market shows you the process and identifies the key concepts to know before you begin.view all

ビデオ | 15 minutes

This video about South Korea's medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

This chart illustrates the steps in South Korea's MFDS medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

An overview of the medical device regulations in South Korea, including the QMS compliance, classification, and submission requirements.view all

記事 | 4 pages

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

Interested in selling your medical device or IVD in South Korea? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

A comprehensive list of medical device regulations in South Korea with links to the original documents.view all

規制 | Downloadable PDFs

This video about Taiwan's medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

This chart illustrates the steps in Taiwan's TFDA medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

Interested in selling your medical device or IVD in Taiwan? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

Learn about the regulatory structure in Taiwan and major medical device regulations.view all

 

A comprehensive list of medical device regulations in Taiwan with links to the original documents.view all

規制 | Downloadable PDFs

This video about Turkey's medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

This chart illustrates the steps in Turkey's medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This white paper provides an overview of common practices and business customs you should follow to optimize your success entering the Middle East.view all

記事 | 5 pages

Interested in selling your medical device or IVD in Turkey? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

Learn about the regulatory structure in Turkey and major medical device regulations.view all

 

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

Use this calculator to see how many calendar days it usually takes the US FDA to clear medical devices with the same Product Code.view all

チャート | Interactive Calculator

US FDA 510(k)s have unique content and format requirements. Get an overview of preparing and submitting a 510(k).view all

記事 | 10 pages

Correct classification of a medical device is critical for identifying its proper regulatory route in the United States.view all

記事 | 13 pages

This chart illustrates the steps in the US FDA's medical device approval process and includes a timeline of expected approval.view all

チャート | 2 pages

This video about the United States medical device market gives an overview of the regulatory framework and registration process basics.view all

ビデオ | 4 minutes

This video describes key aspects of the FDA UDI system, why it is necessary, benefits, and when and how device manufacturers need to comply.view all

ビデオ | 5 min

This video series about the United States' medical device market shows you the process and identifies the key concepts to know before you begin.view all

ビデオ | 24 minutes

Learn about the Unique Device Identification (UDI) regulation, how to obtain a UDI number, compliance deadlines, and more.view all

記事 | 5 pages

Discover guidelines, tips, and other useful information about corresponding with the FDA about the clearance of your medical device.view all

記事 | 6 pages

In this video, we discuss what medical device companies should do (and what not to do) before, during, and after a random FDA audit. view all

ビデオ | 4 minutes

Learn about usability engineering studies, including FDA requirements, standards, and how to conduct a usability study.view all

記事 | 7 pages

This white paper provides a high-level overview of the US FDA 21 CFR Part 820 and the implementation process, including timelines and strategies.view all

記事 | 8 pages

This paper describes exactly what to expect from a random FDA audit and how to prepare for the inspector's arrival in a concise checklist.view all

記事 | 9 pages

In this paper, we answer your biggest questions about the obstacles and opportunities of marketing companion diagnostics in the US and Europe.view all

記事 | 5 pages

In this video, we’ll take a look at 21 CFR Part 820, including an overview, key players, important sections, and how to maintain compliance.view all

ビデオ | 11 min

In a 510(k) submission, what testing is required by the FDA to clear the device? While testing requirements are easy to determine for some devices, other devices require intensive research.view all

記事 | 24 pages

In this white paper, we discuss US regulations for wireless medical devices, including submission requirements, risk management, and more.view all

記事 | 6 pages

Learn about substantial equivalence, which is the key to getting your Class II medical device cleared for sale by the US FDA.view all

記事 | 7 pages

Does your medical device contain animal or human cells or tissues? Learn about FDA requirements for these products.view all

記事 | 4 pages

This short video covers FDA classification, how to use the classification database, and useful tips for classifying your medical device.view all

ビデオ | 7 min

Post-market surveillance is a regulatory requirement the US and Europe and helps you ensure your device's safety and effectiveness.view all

記事 | 6 pages

This whitepaper discusses how to bring a novel device to the US market, including common pathways, exemptions, and the de novo process.view all

記事 | 8 pages

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

This white paper addresses Purchasing Controls, one of the biggest QSR compliance vulnerabilities for medical device companies selling in the US.view all

記事 | 7 pages

If you are marketing a device in Europe, the US, or even beyond, the ISO 10993 series is your guide to biocompatibility testing requirements.view all

記事 | 16 pages

A brief look at the United States' medical device market, including potential opportunities and obstacles for manufacturers.view all

 

This white paper US quality assurance requirements for human clinical studies and breaks down the key elements compliant study.view all

記事 | 5 pages

ISO 11135:2014 is recognized as the international standard for process management and validation requirements of Ethylene Oxide (EO) sterilization.view all

記事 | 12 pages

Learn about the regulatory structure in the United States and major medical device regulations.view all

 

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

ISO 13485:2016 provides an international QMS standard and introduces notable changes, particularly in the area of risk management.view all

記事 | 16 pages

In this recorded webinar we cover the major changes that have been made and tell you what needs to be done before you seek recertification by your Notified Body.view all

ビデオ | 1 hour live webinar

Risk management requirements for medical device manufacturers will expand significantly with the publication of ISO 13485:2016. Manufacturers will have to approach risk management controls in a new way, and change how they integrate it with their quality view all

ビデオ | 1 hour webinar

This white paper discusses requirements and best practices for translating device labeling and Instructions for Use (IFU).view all

記事 | 8 pages

This article discusses how to better anticipate and solve the common problems all auditors face, and some solutions.view all

記事 | 1 web page

It's not always clear what regulations apply to software. Regulatory authorities across the globe have provided little (or confusing( guidance, leaving developers to question: When is software considered a medical device?view all

記事 | 6 pages

Post-market surveillance is a regulatory requirement the US and Europe and helps you ensure your device's safety and effectiveness.view all

記事 | 6 pages

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.view all

ビデオ | 7 min

In this video, learn about medical device labeling symbols, their meanings, and how they communicate important product information.view all

ビデオ | 11 min

If you are marketing a device in Europe, the US, or even beyond, the ISO 10993 series is your guide to biocompatibility testing requirements.view all

記事 | 16 pages

Learn about the standards, requirements, and benefits of medical device labeling and symbols. Includes a list of common symbols and meanings.view all

記事 | 7 pages

This table gives you an idea of how much money is spent on healthcare in various countries worldwide, and who pays for it.view all

チャート |

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.view all

チャート | Interactive Page

In this white paper you learn about the steps a company should consider before marketing their wireless medical device in international markets.view all

記事 | 5 pages