In November 2013, SGS hosted a complimentary one-hour webinar (45-minute presentation/15-minute Q&A) to explain the changes in auditing and technical file assessments for medical devices, which came into force at the start of 2014. The webinar available for streaming here outlines the main changes in the two EU Commission documents published on 24 September 2013 and helps manufacturers plan compliance and management of new features such as unannounced audits.
Who Should View the Webinar?
The webinar is aimed at medical device manufacturers and organisations who have certification under one of the European medical device directives or who plan to obtain such certification. The relevant directives are Active Implantable Medical Devices, 93/42/EEC Medical devices and 98/79/EC In Vitro Diagnostic Medical Devices. Those people involved with or responsible for quality systems, regulatory affairs, product design, manufacture or clinical activities will also find the subject relevant.
As part of the SGS service to keep manufacturers up-to-date with latest changes in the regulatory framework, SGS regularly produces industry-leading resources that explore a variety of sector developments.
Key topics discussed in the webinar: ‘Changes to CE Certification of Medical Devices: Preparing for Changes in Auditing and Technical File Assessments’, include:
- Introduction and Background
- Changes to Audits and Quality Management Systems
- Unannounced Audits
- Changes to Technical Documentation and Technical File Assessments
- Changes for Notified Bodies
- Changes to Contracts
- Priority Actions for Manufacturers
Chris Jepson, SGS Global Manager Medical Devices, hosts the webinar and manages SGS’ global medical devices activities. Chris is currently Chair of NB MED, the forum of Medical Device Notified Bodies, Industry, EC Commission and other interested parties. In this role, he is involved with the ongoing European discussions on changes to current Notified Body policy and the future revisions to the medical device directives. Chris is a chartered materials engineer and fellow of the Chartered Quality Institute.
For more information on this webinar topic, and many others, keep up-to-date by visiting SGS Medical Devices.
Click here to access the webinar recording: 'Changes to CE Certification of Medical Devices: Preparing for Changes in Auditing and Technical File Assessments'.