When developments in the medical devices industry require a more in-depth explanation – such as the changes that came into force in 2014 for auditing and technical file assessments in the EU – then sign up for SGS’ complimentary one-hour webinars and stay informed. The SGS webinar (45-minute presentation/15-minute Q&A) on the main changes in two EU Commission documents published on 24 September 2013 helps manufacturers better plan compliance and management of new features such as unannounced audits.

Webinar Summary

Changes in auditing and technical file assessments that affect medical device manufacturers or organisations requiring certification under the relevant EU directives (i.e. Active Implantable Medical Devices, 93/42/EEC Medical Devices, 98/79/EC In Vitro Diagnostic Medical Devices) are outlined in the webinar.

Topics include:

  1. Introduction and Background
  2. Changes to Audits and Quality Management Systems
  3. Unannounced Audits
  4. Changes to Technical Documentation and Technical File Assessments
  5. Changes for Notified Bodies
  6. Changes to Contracts
  7. Priority Actions for Manufacturers

Webinar Presenter

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.

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