Applying and validating a quality management system for in-house developed medical software

Area of Science:

• Medical Device Regulation
• Software Engineering
• Quality Management Systems

Background:

• The Medical Device Regulation (MDR) introduced in 2021 significantly altered in-house medical device development legislation.
• Practical guidelines for implementing quality management systems (QMS) for in-house medical software are limited.

Purpose of the Study:

• To describe the experience of fulfilling MDR requirements for an in-house developed prediction model classified as medical software.
• To demonstrate the adaptability of existing QMS frameworks for medical software.

Main Methods:

• A QMS based on ISO13485:2016 was implemented, integrating existing data science team procedures.
• Gaps between current software development practices and QMS requirements were identified and addressed through documentation and format standardization.

Main Results:

• 19% of QMS elements were not applicable to the software development project.
• For applicable elements, 32% required no additional documentation, 23% needed supplementary information, and 45% necessitated the use of standard QMS formats.

Conclusions:

• It is possible to adapt a QMS designed for physical medical devices to comply with MDR for medical software.
• Successful adaptation requires minimal effort when a structured software development methodology is already in place.