Short Term or Part-time Medical Device QA/RA Outsourcing

In today's fast changing and increasingly complex regulatory environment, it can be difficult to manage 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 manage 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 QA expertise in numerous 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, accommodate a parental leave of absence, 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 quality assurance and regulatory affairs outsourcing services include:

• Temporary full-time, part-time, or "as needed" consulting for QMS compliance 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 outsource QA/RA to Emergo?

• Offices throughout North and South America, Asia, Europe, and the Middle East.

• Official in-country representative for 2,000+ 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.

Emergo by UL can provide eQMS support in strategic alliance with Greenlight Guru. This helps you leverage an eQMS system designed specifically for the medical device industry. Ask us to schedule a demo so you can explore a software solution that connects with your processes, people, and data.

Contact us for more information on our QA and RA outsourcing services.

Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries.  This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers.  UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.