"As Needed" Quality Assurance (QA) and Regulatory Affairs (RA) Outsourcing
In today’s fast changing and increasingly complex business environment, you need to be nimble and efficient. That’s why more and more companies are choosing to outsource some medical device regulatory affairs and quality assurance tasks as a way to ensure ISO and FDA compliance. In small and medium sized medical device companies, regulatory affairs and quality assurance tasks are often added to the responsibilities of senior management. As a result, regulatory compliance and ongoing quality assurance and 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, Australian TGA or Health Canada.
Medical device regulatory affairs and QA outsourcing isn’t limited to smaller companies. Larger companies with established QA/RA departments often seek 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 importantly, 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.
- Quarterly 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 for FDA GMP quality systems.
- FDA Form 483 letter response.
- Complaint handling, contract review and surveillance audits.
- Document control and maintenance.
Why you should choose Emergo for quality assurance (QA) outsourcing and regulatory affairs:
- We have offices in the US, Europe, Canada, China and Australia and are very familiar with regulatory affairs issues in those areas.
- Emergo is a registered US Agent, EU Authorized Representative, China After Sales Agent/Legal Agent or Australian Sponsor for hundreds of medical device or IVD companies. In short, government regulators know us very well and we know where to get answers on behalf of our clients.
- 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.
- RA and QA outsourcing gives you the flexibility to respond to issues quickly, and concentrate on core business goals.
- Outsourcing QA/RA tasks only when you need it saves money.
- You make continuous improvements to your quality management system to operate more efficiently.
- Our highly experienced staff consultants and Certified Lead Auditors specializing in medical devices and IVD.
- Our fixed pricing with no monthly retainers means no unexpected surprises.
Contact us today for more information on Emergo Group's medical device QA and RA outsourcing services.
