Unannounced Audit Case Study: A Medical Device Manufacturers Experiences

In an effort to strengthen medical device safety and efficacy, the EU Commission implemented the Recommendation of 2013/473/EU, a policy for conducting unannounced audits for products bearing the CE mark. Notified bodies began performing these requirements, which are also applicable to critical suppliers and subcontractors, in 2014 and are responsible for conducting an unannounced audit once every three years. Legal manufacturers have predominately been the focus of such audits, with some device organizations noting their surprise to receive an unannounced visit so shortly after the initiation date. Sharing recent experience with the unannounced audit program alongside core areas of inspection by auditors from the manufacturer perspective will provide insight and clarification for others facing an upcoming audit scenario and will be of particular interest to those that have not yet experienced an unannounced audit.

  • Practical logistics planning
    • Facility access
    • Test samples
  • Audit focal points, surprises and future training activities
  • Managing unannounced visits in relation to other audits
  • Supplier management
  • Best practices for audit preparation

Patricia Schnoor
Director of Quality & Regulatory Affairs

Brooke AkinsContact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693