Course Details

European Harmonization: MDR requirements and progress on key standards and labelling

Course Area

Medical Devices

Availability

Available for 90 days after enrollment

Approximate Course Run Time

1 hour

Continuing Education Units

0.1

Course Fee

No charge

E-learning content is available on demand!

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Course Details

There are 400 standards harmonized under the EU Medical Device Directives (AIMD, MDD and IVDD). When the Directives are replaced by the new Medical Devices and IVD Regulations the standards will no longer provide presumption of conformity to the Regulations.

This webinar will cover the following:

  • Status of the transition on harmonized standards
  • Standards and Common Specifications
  • Proposal for inclusion of new standardized symbols EN ISO 15223
  • Brief update on key standards

Please join Paul Sim, Knowledge Solutions - Medical Devices Knowledge Manager, for an insight into these key changes for your business and how you can start preparing now.

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Private Class

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Questions?

For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

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