The software industry faces important challenges with new MDR and IVDR. Maintaining an Agile development environment while fulfilling regulatory requirements induces the need for strategies.

In an initial step, an IEC/EN 62304 training of the development team is almost a necessity. Medidee fulfills this need by delivering specialized training either in-house or as part of the regular training offer.

Then the software development team is stimulated to write product requirement that may require different levels of stratification. By establishing a system approach, and by structuring requirements, the team is empowered to master the inventory of constraints applicable to the considered software. At this stage, Medidee consultants may have to coach the team or to review the documentation.

From development, planning stages up to release, Medidee proposes the following services:

  • confirmation of classification
  • training of software team on 62304
  • planning of software compliance activities
  • management of software requirements
  • software risk management
  • design of test protocol
  • review of compliance files
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