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 such as the potential need for new contractual agreements, operating procedures, and preparedness planning among staff.
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
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.
Fill in your details below to register for the webinar: