The Digital Health industry faces important challenges with new requirements and higher classifications introduced by the MDR and IVDR. For companies, maintaining state-of-the-art, Agile development practices while fulfilling regulatory requirements brings the need for well-defined strategies. 

In an initial step, an assessment of existing methodologies and documentation, combined with IEC/EN 62304 training of the development team is almost always a necessity. Medidee fulfils this need by delivering specialized training either in-house or as part of the regular training offer.

Then, the software development team is encouraged to write product requirements 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. The implementation of risk management methodologies also supports a compliant yet pragmatic software testing strategy. At this stage, Medidee consultants will coach the team and/or review the documentation as needed. 

medidee software, Medidee Medical Services

Read how Medidee's Digital Health Services apply in a real context:

A company operating in the MedTech field got in touch with Medidee seeking regulatory advice. This company was considering developing a mobile app for tracking a set of observed symptoms on a baby with timestamps and keywords. The main purpose was to ease the reporting of observed baby behaviours by the mother to the practitioner. Our team quickly noticed that most of the features on this app would not trigger the classification as a medical device under 93/42 MDD or 2017/745 MDR. However, one feature attracted our attention: the ability of the mobile app to self-detect some patterns and to recommend an immediate transfer to the hospital. Read more

From planning to development, up to market 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
  • clinical validation of artificial intelligence models
  • cybersecurity and data protection strategies

Contact Medidee to discuss your needs