Medical Device Software Development.

Beyond the IEC 62304 Standard.

Innovation with Patient Safety in Mind

The increasing popularity of telemedicine, precision medicine, and mobile health services has drawn the attention of stakeholders to take advantage of these technologies and find new business opportunitiesIn this context, software, as the enabler of digital health services is evolving rapidly to produce very sophisticated and accurate solutions (i.e. Artificial Intelligence models), allowing complex and powerful systems (i.e. cloud processing), while becoming ubiquitous (i.e. accessible everywhere from mobile devices). Nonetheless, software is not exempt from failures that could impact patient safety. The Medical Device Regulation MDR2017/745 defines safety and performance requirements (GSPR) for software development, testing and distribution that challenge manufacturers.

Key Challenges in Software Development

Regular Software Updates​

Market requirements, cybersecurity improvements and bug fixing continuously trigger software updates. The EN/IEC 62304 Standard calls for a change management process, which must be aligned with the other QMS procedures. Not finding the optimal trade-off between change request, software update processes and documentation can yield to inefficient software lifecycle or even non-conformities.

Development Tools Complexity and SOUP

Complex environments for software development, such as requirements management, automation tools or artefacts control systems must be validated by manufacturers. The integration of Software of Unknown Provenance (i.e. software not initially designed for medical applications) and their regular updates represent significant risks that shall be handled with care.

Software Clinical Validation

EN/IEC 62304 does not cover validation of software products, which is a demanding task. According to the MDCG2020-1, an appropriate level of Clinical Association, Technical Performance and Clinical Performance is required to fulfil MDR requirements. Furthermore, if the software integrates Artificial Intelligence models, Good Machine Learning Practices must be followed.

How Medidee Supports your Software Development Activities

Secure Software development of medical devices is of major significance to fulfilling the requirements (GSPR) set by the Medical Device and In Vitro Diagnostic Regulations.Our team is by your side in specific key areas requiring particular attention:

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Setting-up adequate processes for product roadmap and software maintenance, recognizing the need for regular updates while creating supportive documentation to demonstrate compliance

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Leveraging the company’s existing development tools to meet requirements for traceability and documentation. Conducting risk analyses, supporting a pragmatic yet compliant approach for their validation.

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Elaborating the adequate clinical development plan supporting medical claims, while defining an adequate strategy for software verification

Proactivity that Enables Innovation

Long timelines (up to 18+ months from beginning to assessment) and high expectations from Notified Bodies create a complex scenario where manufacturers must excel to be successful in their Conformity Assessment.


Furthermore, the relevance of Software Design & Development is paramount to creating and maintaining comprehensive Technical Documentation that complies with all the applicable requirements.


Medidee works proactively by your side, to ensure that you are prepared to pass your Conformity Assessment confidently and in a timely manner.

Contact Medidee to discuss your needs