target group

Employees from product development, production, quality assurance and regulatory affairs.

content

From the idea for the development of a medical product to the manufacture of the pilot series and handover to production, a large number of regulatory requirements have to be met. The EU-MDR only reflects one part of the requirements, albeit the most important part for the European market, but in many cases it is supplemented by other directives, regulations and laws.
Wherever approval is sought, explicit proof must be provided of how the medical device was developed and how it is ensured that it is safe and functional. Elementary components of this proof are the verification of the development results on the basis of a specification (design verification) and the validation of the product against the requirements of the specifications and requirements specification (product validation). A regulatory requirement that can now be found worldwide. The seminar presents the steps to prepare and carry out design verification and product validation. Using a practical example, a possible path from the idea to the "finished" product is shown, which provides sustainable evidence and avoids the typical pitfalls.

topic overview

  • Introduction, example
  • Development processes (from the idea to the product)
  • Specific requirements for the development of medical devices
  • Particularities of the requirements for Design Verification (DV) and Product Validation (PV) from the different approval regions
  • Development of a DP and PV strategy for a product
  • Documentation of DV and PV
  • Differentiation from other validation tasks

previous knowledge

Basic knowledge of dealing with regulatory requirements and quality requirements is necessary.

KONTAKT:
Max-Planck-Straße 17,  Tuttlingen
Beruflichen Bildungsstätte Tuttlingen & Online

 

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