Medical device manufacturers are focused on bringing innovative yet safe products to patients worldwide. Manufacturers need predictability and transparency during the regulatory process from product development, through clinical investigation to product clearance and market launch. The speed and reliability of the certification process is key to setting correct stakeholder expectations and avoiding unnecessary surprises.

Medical device manufacturers looking to certify for CE Marking and/or management system standards, such as ISO 13485, 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.