Unannounced Audits: An Overview of the Commission Recommendation, Strategies for Preparing in Advance, and A Notified Body’s Experience to Date

1 Hour and 35 Minute Video | BSI

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

 

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
  • Legal Counsel
  • Audits

 

 This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.

Vicky Medley

 

 

 

 

 

Vicky Medley
Head of QMS – Medical Devices
BSI

Vicky has worked within the Medical Device industry for 18 years and is currently responsible for BSI’s Quality Management System assessments that support BSI certification for CE Marking, ISO 13485 and related medical device schemes globally. With 9 years in the BSI Notified Body, Vicky’s previous roles included Team Leader within the Orthopaedic & Dental Team and as a Technical Specialist / Scheme Manager conducting reviews of technical files and design dossiers. Prior to joining BSI Vicky worked for Johnson & Johnson for 9 years across a number of roles in a technical capacity, encompassing the R&D, manufacturing, quality assurance and regulatory aspects of a wide range of devices.

Paul Sim

 

 

 

 

 

Paul Sim
Regulatory Affairs Manager – Medical Devices
BSI

Paul has worked in the healthcare industry for 34 years and is currently Project Managing BSI’s implementation of EU Commission Recommendation 2013/473/EU dealing with Unannounced Audits. Joining BSI in August 2010 and co-leading the BSI effort with the Saudi Food & Drug Authority with the implementation of the SFDA Medical Device Interim Regulations, along with a number of other CAB’s (Conformity Assessment Bodies).  Previously he held senior RAQA leadership positions at Spacelabs Healthcare, Teleflex Medical, Smiths Medical, Ohmeda (formerly The BOC Group healthcare business).

 


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