LANGUAGE: English

WHERE: United States

COST: US/CAD $1095

LEVEL:
 
Technical Training

PARTICIPANTS RECEIVE:
  • Copies of presentation slides
  • Course Manual
  • Soft copies of forms/plans
  • Certificate of course completion

DURATION:
 
2 Days
 
COURSE MATERIAL AND APPROACH:
 
This course has been prepared by the medical device specialists of SGS and the content approved by SGS United Kingdom Ltd. SGS United Kingdom Limited is approved as Notified Body 0120, a CMDCAS Recognized Registrar, UKAS accredited certification body 005, under the FDA Approved Persons Program and is recognized by many other regulatory authorities including those in Australia and Taiwan. Other medical device approvals in the SGS group include SGS Japan Inc as a JPAL Registered Certification Body and SGS Hong Kong Ltd recognized by the Hong Kong Medical Device Control Office.
LEARNING OUTCOMES:
  • Understand the requirements of ISO 13485:2003 and their interpretation.
  • Understand the quality system requirements of EC directives 93/42/EEC and 98/79/EC.
  • Prepare quality management system documentation to meet ISO 13485:2003 and EC Directives 93/42/EEC and 98/79/EC.
  • Use the references and guidance documents

WHO SHOULD ATTEND?

Manufacturers of medical devices/IVD's. Quality system managers, regulatory affairs managers, technical managers or managers responsible for technical files including anyone requiring knowledge on this topic.