Preparing for the New Changes in Notified Body Audits and Technical File Reviews
Nov 28, 2012
Nov 28, 2012
SGS invites you to attend the 45-minute complimentary webinar "Preparing for the New Changes in Notified Body Audits and Technical File Reviews" on November 28, 2012.
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 are starting to occur now and 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 will be discussed. The actions that manufacturers should take to prepare for these changes will also be covered.
- 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 Question and Answers
This complimentary webinar is aimed at medical device manufacturers and organizations 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 find the subject relevant.
Mr. Chris Jepson BSc., FCQI, MIMMM, C Eng SGS Global Manager- Medical Devices
11:00 a.m. San Francisco
02:00 p.m. New York
07:00 p.m. London
Cost: No Charge
Systems & Services Certification
Vice President, Global Marketing & Business Development
1, place des Alpes
t +41 22 739 9161