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SGS has two complimentary webinars now available for playback on the latest developments in the medical devices industry. These webinars are part of the SGS service to keep manufacturers up to date with changes in the regulatory framework. Read on to find out the full details and links for each webinar.

Webinar One: Preparing for the New Changes in Notified Body Audits and Technical File Reviews

The objective of this 45-minute complimentary webinar is to inform manufacturers of the likely changes they will start to experience in audits and technical documentation reviews from Notified Bodies. These changes, started in 2012, will continue to be introduced during 2013.

These changes are not those that will be introduced by the revision of the medical device directives but the more immediate tightening of conformity assessment following the PIP breast implant scandal and acknowledgement that Notified Bodies and certification bodies are not operating to the same standard.

The influence of the EC Commission, the Notified Bodies Code of Conduct and the IAF Mandatory Guidance MD 9 is discussed. The actions that manufacturers should take to prepare for these changes are also covered.

Topics

The webinar covers five topics:

  1. Why is change needed?
  2. Where and how are these changes being agreed?
  3. Changes to audits and actions for manufacturers
  4. Changes to technical file reviews and actions for manufacturers
  5. Opportunity for Q&A

Target audience

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. The webinar topic is relevant for anyone involved with or responsible for quality systems, regulatory affairs, product design, manufacture or clinical activities.

Presenter

Mr. Chris Jepson BSc., FCQI, MIMMM, C Eng SGS Global Manager- Medical Devices

Mr. Jepson manages the SGS global medical devices activities and 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. He is a Chartered Materials Engineer and a Fellow of the Chartered Quality Institute.

Webinar link

Please click here to find the recording of the webinar.

Webinar Two: How to Undertake and Document a Clinical Evaluation

The objective of this one-hour complimentary webinar is to inform manufacturers of current challenges in meeting the needs of Annex X of 93/42/EEC, and utilisation of European Commission guidance to address requirements.

The impact of the recent high profile issue with metal-on-metal hip replacements has highlighted the need for robust clinical evaluations to be performed, and Competent Authorities are focusing on the clinical evaluation process and vigilance.

The basic requirements set out within Annex X of the directive are discussed, and using MEDDEV guidance best practices is described, addressing pre and post CE marking clinical activities.

Topics

The webinar covers five topics:

  1. Essential requirements and Annex X
  2. Current issues identified with clinical evaluations
  3. Pre CE marking requirements for clinical evaluation
  4. Post market clinical follow-up activities
  5. Opportunity for Q&A

Target audience

This 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 90/385/EEC Active Implantable Medical Devices and 93/42/EEC Medical Devices. The webinar topic is relevant for anyone involved with or responsible for quality systems, regulatory affairs, product design, manufacture or clinical activities.

Presenter

Mr. Adrian Keene, SGS Clinical Affairs and Regulatory Manager.

Adrian Keene has responsibility for conformity assessment activities of all high-risk (class III) devices under the Medical Device Directive for SGS. He has over 19 years experience in the medical device industry, and previously held the role of Technical Manager – Medical Devices at the UK Notified Body LRQA. Prior to that, he worked in the medical device industry, most recently in the areas of product safety and risk management. He joined the medical devices industry following postgraduate research and a BSc (Honours) in Toxicology and Pharmacology. He also holds a Diploma in Managing Medical Product Innovation from the Scandinavian International Management Institute. Adrian is a UK expert for ISO/TC 194 (Biological Evaluation of Medical Devices), and is an active participant in the forum of Medical Device Notified Bodies, NB-MED.

Webinar link

Please click here to find the recording of the webinar.

Further Information

Contact the Medical Devices Team today to see how we can help your business. Kindly click on the “Email Us” link on this page.