Medical device manufacturers looking to certify for CE Marking and/or management system standards, such as ISO13485, should seek a focused medical device certification body that has sufficient professional resources to deliver to expectations including:
- Quality Management System Assessors with vast experience in the medical device industry, who undergo ongoing training to maintain strong current credentials
- Product Experts who thoroughly understand the medical device technology that they review from years of hands-on design, development and clinical experience
- Microbiologists to ensure confidence in controlled environments and sterilization, which if not done effectively, places patient safety in significant jeopardy
Manufacturers need a highly competent, customer-focused certification/notified body that understands the challenges of the regulatory and quality environment, and always in tune with state of the art.