Regulation and quality requirements of medical devices in USA

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  • Knowing the regulatory context for medical devices in the US, 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


Acquiring the basics

Programme summary

  1. Introduction and objectives
  2. Knowing one’s contact persons: FDA
  3. Being able to classify one’s medical device
  4. Understanding the administrative requirements for market launch
  5. Understanding quality system requirements and other regulatory requirements
  6. Preparing for an FDA inspection
  7. Taking costs and time frames into account
  8. Anticipating postmarket constraints
  9. Taking strategic decisions for market launch
  10. Conclusion


There is no prerequisite for this training.


1 day
7-hour classroom attendance


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