In today's fast changing and increasingly complex regulatory environment, it can be difficult to ensure compliance to an ever-changing array of medical device regulations in multiple countries. Many medical device companies are choosing to outsource some of their regulatory affairs and quality assurance tasks as a way to ensure compliance in these worldwide markets.
Helping device companies with ongoing QMS 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 system improvements may not receive the attention they require. This can lead to potentially negative and costly consequences such as lost customers, non-compliant suppliers or serious challenges from Notified Bodies, the US FDA, European Competent Authorities and other Ministries of Health.
Registration and regualtory expertise for global markets
Medical device regulatory affairs and QA outsourcing is not limited to smaller companies. Larger companies, even those with established QA/RA departments, often seek our assistance to supplement their in-house expertise, allowing them to overcome staffing shortages, provide training or obtain independent auditor assistance. Whatever your situation, Emergo can help you maintain regulatory compliance, enhance your quality system, and most importantly, concentrate on your core business objectives.
Our medical device quality assurance (QA) and regulatory affairs (RA) outsourcing services include:
- Full or "as needed" consulting for ISO and/or GMP quality assurance and regulatory affairs.
- Audits of your quality management system or a supplier's quality system.
- Review of corrective actions and recommendations for resolution.
- Supporting quality metrics and analysis as part of the management review meetings.
- Internal auditor training, risk management, quality system, or other training needs.
- Complaint handling, contract review and surveillance audits.
- Document control and maintenance of the quality system.
- Responding to FDA 483 Observations, Warning Letters and Notified Body audit findings.
Why choose Emergo for quality assurance outsourcing and regulatory affairs?
- Offices throughout North and South America, Asia, Europe and the Middle East.
- Official in-country representative for 1,000+ medical device and IVD companies worldwide.
- 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 specializing in medical devices and IVD.
Contact us for more information on our QA and RA outsourcing services.