Quality Assurance (QA) and Regulatory Affairs (RA) Outsourcing
In today's fast changing and increasingly complex regulatory environment, many companies are choosing to outsource some medical device regulatory affairs and quality assurance tasks as a way to ensure quality system and regulatory compliance. In smaller medical device companies, regulatory affairs and quality assurance tasks are often added to the responsibilities of personnel who do not have the knowledge or experience to handle them. As a result, regulatory compliance and ongoing quality assurance/improvement often does not receive the attention it requires. This can lead to potentially negative and costly consequences such as lost customers, non-compliant suppliers or serious challenges from the US FDA, European Competent Authorities, Notified Bodies, Australian TGA, Health Canada, or Japanese PMDA.
Medical device regulatory affairs and QA outsourcing is not limited to smaller companies. Larger companies with established QA/RA departments often seek our assistance with certain aspects of their quality and regulatory compliance activities to complement their in-house expertise, allowing them to overcome staffing shortages, provide training or obtain independent auditor assistance. Whatever your situation, Emergo Group can help you maintain regulatory compliance, enhance your quality system, and most important, concentrate on core business objectives.
Our medical device regulatory affairs (RA) and quality assurance (QA) outsourcing services include:
- Full or "as needed" consulting for ISO and/or GMP quality assurance and regulatory affairs.
- Audits of your FDA GMP and/or ISO 13485 quality system or a supplier's quality system.
- Review of corrective actions and recommendations for resolution.
- Attendance at executive management review meetings.
- Internal auditor training or other training needs.
- Complaint handling, contract review and surveillance audits.
- Document control and maintenance.
Why choose Emergo for quality assurance (QA) outsourcing and regulatory affairs?
- Offices in the US, Europe, Canada, Japan, China and Australia.
- Emergo is a registered US Agent, EU Authorized Representative, Chinese Legal Agent/After Sales Agent, Japanese MAH, and/or Australian Sponsor for hundreds of medical device or IVD companies.
- Medical device regulatory affairs and quality assurance is our business. We stay on top of the latest regulatory developments and are active in several government and industry associations.
- Flexibility to respond to issues quickly and concentrate on core business goals.
- Outsourcing QA/RA tasks on an "as needed" basis can be very cost effective.
- Continuous improvements to your quality management system to operate more efficiently.
- Highly experienced staff consultants and Certified Lead Auditors specialized in medical devices and IVD.
- Pre-approved, fixed pricing, where applicable, with no monthly retainers means no unexpected surprises.
