SGS Webinars and Whitepapers: Explore, Inform and Discuss
SGS regularly produces industry-leading resources that explore a variety of sector developments. Our interactive webinars are one such resource that keeps you up-to-date on all the latest happenings in the medical devices industry.
At SGS, our popular series of interactive webinars and in-depth whitepapers explore, inform and discuss key topics of interest in the medical devices industry. Read on to find out how to make sure you don’t miss a great opportunity to learn from the world’s leading inspection, verification, testing and compliance company.
Webinar: ‘Preparing for the New Changes in Notified Body Audits and Technical File Reviews’
This 45-minute webinar explores the likely changes manufacturers will start to experience in audits and technical documentation reviews from Notified Bodies. Started in 2012, and continuing 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.
Hosted by Chris Jepson, SGS Global Manager, Medical Devices, the webinar is aimed at medical devices manufacturers and organisations who have certification under one of the European medical device directives or who plan to obtain such certification. The webinar is also relevant for anyone involved with, or responsible for, quality systems, regulatory affairs, product design, manufacture or clinical activities.
‘Preparing for the New Changes in Notified Body Audits and Technical File Reviews’ webinar covers the following topics:
- Why is change needed?
- Where and how are these changes being agreed?
- Changes to audits and actions for manufacturers
- Changes to technical file reviews and actions for manufacturers
- Opportunity for Q&A
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: ‘How to Undertake and Document a Clinical Evaluation’
This one-hour complimentary webinar is to inform manufacturers of current challenges in meeting the needs of Annex X of 93/42/EEC, and utilization 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.
Hosted by Adrian Keene, SGS Clinical Affairs and Regulatory Manager. 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 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.
‘How to Undertake and Document a Clinical Evaluation’ webinar covers the following topics:
- Essential requirements and Annex X
- Current issues identified with clinical evaluations
- Pre CE marking requirements for clinical evaluation
- Post market clinical follow-up activities
- Opportunity for Q&A
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.
Whitepaper: ‘Medical Device Regulations In The Main Global Markets’
Medical devices is one of the world’s fastest growing industries. For manufacturers, staying up-to-date on how to gain market access in specific regions, and other key global markets, is crucial. With this in mind, SGS has created a comprehensive white paper outlining the market entry requirements and regulatory frameworks of 13 individual regions in a simple and easy to understand manner.
The paper summarises, for each of the 13 markets, the main aspects of medical device regulations that currently apply. It gives an indication of the main requirements, approvals and registrations needed by the manufacturer before devices can be legally sold in that market. Each section contains links to related external websites for easy access to all additional information.
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