Many medical device manufacturers don't realize that Notified Bodies can perform unannounced audits of your quality system. They can even audit your critical suppliers with very little notice. In this whitepaper, we answer your biggest questions about Notified Body audits and how to reduce the potential for an unannounced critical supplier audit, including:
- An overview of the role of Notified Bodies in European conformity
- What may be included in the Quality System Assessment
- How often to expect Unannounced Audits
- The importance of internal supplier audits
You'll learn all this and more in this 9-page white paper.
About the Author
Alexandre Pétiard is a Senior Quality & Regulatory Consultant at Emergo. With more than eight years of experience in regulatory affairs, his expertise includes design control support, technical file preparation, clinical evaluation report, risk management file, 510(k), quality system implementation and audits, and post-market surveillance and vigilance activities. Mr. Pétiard previously held regulatory positions at Covidien, Integra LifeSciences, and Alcis.