Regulatory Requirements on Medical Devices

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The agenda proposal aside has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

Agenda Proposal

08:00 – 08:30 Welcome, Introduction, Presentation of the Speaker
08:30 – 09:30 Regulatory Requirements
  • European Directive
  • FDA
  • Norms
  • Notified Body
09.30 - 10.30 Differences between EC and FDA Requirements
  • European Requirements
  • FDA Requirments
  • Differences and common interests
10.30 - 10.45 Break
10.45 - 11.45 CE-Certification
  • Requirements of the EC Directive
  • Use of the norms
  • Certification Process
11.45 - 12.45 ISO Certification
  • Implementing a system
  • ISO 9001 as basic norm
  • ISO 13485 as a basic norm
  • Procedure of certification
12.45 - 13.45 Lunch
13.45 - 14.45 Technical Documentation
  • Content of the TD
  • TD as a linking document between production and quality control
  • Change Managemen
14.45 - 15.00 Break
15.00 - 16.00 Device History File/Device Master Record
  • Content
  • Link to TD
16.00 - 17.00 Special Requirements for Medical Devices
  • Risk analyses
  • Sterilisation
  • Validation of processes
  • Supervision of contract manufacturer
17.00 - 18.00 Performance of Audits
  • Preparing for an Audit
  • Performance of an Audit
  • Nuts and bolts of an Audit
  • The Audit report
18.00 - 18.30 Discussion

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