UNANNOUNCED AUDITS OF MEDICAL DEVICE CRITICAL SUBCONTRACTORS AND CRUCIAL SUPPLIERS

About the Product
Includes 1 hour and 30 minute Windows Media Video File and PowerPoint presentations for immediate download.

The EU recommendation on unannounced audits applies not only to medical device manufacturers, but also to device critical subcontractors and crucial suppliers who contribute to the main product design, development, and manufacture. The more significant this contribution is, the more likely it is that the manufacturer’s notified body will also audit the supplier or subcontractor.

The primary challenge for all device manufacturers is that a precise definition of what is and is not considered a critical subcontractor and crucial supplier is unclear at this time. Non-compliance on behalf of the supplier or subcontractor will result in major repercussions for a manufacturer because it will cause the notified body to suspend or revoke the CE certificate for the device(s) concerned. Therefore, adequate understanding of the regulation is necessary to ensure successful audits. In addition, manufacturers must accommodate for unannounced audits in their agreements with suppliers and subcontractors in order to ensure their cooperation with unannounced audits.

• Criteria for determining if a subcontractor/supplier is significant
• Manufacturer responsibilities specific to suppliers/subcontractors
• Key considerations in agreements with suppliers/subcontractors
• How to ensure that the subcontractor / supplier completes an unannounced audit successfully

Speaker:
Erik Vollebregt
Lawyer and Founding Partner
Axon Lawyers

Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:

• Regulatory Affairs
• Quality Assurance
• Supplier Quality
• Legal Counsel
• Audits