Learning Marketplace

Unannounced Audits: The requirements, BSI's model, implementation and feedback

European medical device regulations are undergoing many significant changes that will impact manufacturers, suppliers, and Notified Bodies. One major and immediate change is the EU Commission requirement for Notified Bodies to conduct Unannounced Audits on manufacturers of CE marked products.

Experts from BSI will cover key aspects of the new requirements as well as BSI's model, implementation and feedback on our experience of conducting Unannounced Visits to date. Other important details will include:

  • Typical audit frequency and duration
  • Areas of R&D, operations, and testing that will be subject to audit
  • Types of subcontractors that are potential candidates for Unannounced Audits
  • BSI's experience with Unannounced Audits
  • How to prepare for visits

Who should attend

  • Quality and regulatory professionals
  • Those involved in audits and regulatory compliance
  • Clinical affairs experts
  • Senior business sector and product managers
  • Legal counsel

Presenters

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.

John Howlett: Head of Notified Body - Medical Devices, BSI

John Howlett is Head of Notified Body within the BSI Healthcare Group and has worked in this role for more than 10 years. He has been employed by BSI for over 30 years, 14 of which have been within the Systems & Conformity Assessment areas before transferring to the Medical Devices Notified Body in 1998. In his current role John is actively involved in the review and implementation of the directives and he represents BSI on a range of European and UK Medical Device Committees. Originally qualified in Mechanical and Production Engineering, John spent more than 15 years in the industry, mainly within the Quality Assurance sectors.

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).