Engineers bring innovation to life. In the past years, the MedTech Innovation community probably expanded with the inclusion of more and more non-conventional products that require development competencies more belonging to BioTechs or even pharmaceuticals.

Still, classic engineering competencies remain systematically necessary when it comes to industrializing, testing a product or validating a process.

The regulatory process has different impacts on engineering activities. On one side, the regulatory, clinical and quality processes impose an acute level of expectation for precision and coherence in the documentation that engineers may perceive as a burden.

On the other side, building a Technical Documentation for a product may also be a great opportunity for valorizing the good engineering work that was invested along the development.

Medidee supports engineers by:

  • providing training on specific product related aspects such as biocompatibility, software, usability, electrical safety
  • building comprehensive design control procedures for the QMS of your company
  • supporting the documentation of requirements and their long-term management
  • structuring and coaching the required risk management activities
  • identifying formal design verification and validation (V&V)  to be executed and solution on how to organize these tests
  • setting up process controls such as process validations