UNANNOUNCED AUDITS: AN OVERVIEW OF THE COMMISSION RECOMMENDATION, STRATEGIES FOR PREPARING IN ADVANCE, AND A NOTIFIED BODY’S EXPERIENCE TO DATE

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The European Commission recently released a recommendation on the audits and assessments performed by notified bodies in the field of medical devices and defined specific requirements for Unannounced Audits. Annex III of the commission recommendation outlines specific criteria for these audits to manufacturers, their critical subcontractors and crucial suppliers, and is applicable to any manufacturers with a CE certificate from a notified body. While the industry has been heavily focused on the future potential changes to the medical device and IVD regulation, many have not realized that these unannounced visits are starting now, regardless of when the regulation is finalized.

  • The Requirements for Unannounced Audits
    • Notified Body Implementation
    • Assessment Model
    • Audit Conduct and Timelines
  • What to Expect on the Day
    • Manufacturer Readiness and Responsibilities
    • Budgeting, Preparing and Practicing for Unannounced Visits
    • Subcontractors and Supplier Considerations
  • A Notified Body’s Experience to Date

Speaker:
Vicky Medley
Head of QMS – Medical Devices
BSI

Paul Sim
Regulatory Affairs Manager – Medical Devices
BSI

Brooke AkinsContact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693 
bakins@q1productions.com