Are you ready for a Notified Body audit? The European Medical Devices Directive requires that manufacturers of medium- and high-risk devices apply for an assessment of the manufacturing process and the technical documentation. The manufacturer is responsible for the design, manufacture, packaging and labeling of a device before it is placed on the market, regardless of whether these operations are carried out by the manufacturer or outsourced to a third party. The quality system must ensure that the products conform to the requirements of the Directive at every stage, from design to final inspection.

The Notified Body must audit the quality system to determine whether it meets the requirements, and the auditors have thorough knowledge of the rules on the inspections. Such rules are given in ISO requirements for audit and certification of management systems (ISO 19011:2002) and GHTF guidelines for Regulatory Auditing of Medical Device Manufacturers (GHTF/SG4/N28R4:2008). In this audio conference presentation attendees learn how to use these rules as a guide to Good Auditing Practice for the Notified Body assessment and CE-certification procedures.

This audio conference covers:

• Preparing for a Notified Body audit
• Manufacturer responsibilities during an audit
• What happens if CAPAs are requested
• When a substantial change can lead to an additional audit

About the speaker:

Theo Nusselder is founder and Director of CEpartner4U. Founded in 1997, CEpartner4U offers Authorized Representative and consulting services for medical device manufacturers, including implementing of quality management systems and preparing of technical product documentation. Drawing on his 25 years of experience in the areas of medical research and medical device development, Theo provides CE marking consulting to clients in and outside of Europe. Mr. Nusselder has become a recognized negotiator of borderline medical and in-vitro diagnostic device interpretations, definitions and risk-classifications on behalf of manufacturers with the Competent Authorities and Notified Bodies. As a certified lead auditor for TNO, a medical device Notified Body in Europe, he spent four years performing MDD audits.

Who should attend?

• Regulatory Affairs
• Quality Control
• Quality Assurance
• Consultants
• Legal Counsel
• Manufacturing