Regulation and quality requirements of medical devices in Canada

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Objectives

  • Knowing the regulatory context for medical devices in Canada, its structure and scope of application
  • Knowing the specific requirements related to the medical instrument and the quality system

Audience concerned

Manufacturers/sub-contractors/distributors of MDs:
– Regulatory affairs/quality managers
– Staff with regulatory monitoring tasks
– Department Heads: Production, R&D
– Project Managers, software engineers

Aim

Acquiring the basics

Programme summary

  1. Introduction and objectives
  2. Regulations
  3. Regulatory stakeholders
  4. Regulation SOR/98-282
  5. Regulatory counterparty
  6. Quality requirements
  7. Conclusion

Prerequisites

There is no prerequisite for this training.

Duration

1 day
7-hour classroom attendance

Inscription

Download the registration form

Date des formations CaduCeum Academy

Ref : CANADA

Informations and registration : academy@caduceum.co.uk