CPMS-FLICPMSB Certified Professional for Medical Software - Foundation Level (CPMS-FL)
CPMS Foundation Level (CPMS-FL) covers the fundamentals of developing medical software in a regulated context. It introduces regulatory fundamentals, including the role of the EU Medical Device Regulation (MDR) and key standards such as ISO 13485, ISO 14971, IEC 62304, and IEC 62366-1.
Learners build baseline skills in risk management, software engineering concepts including requirements and software architecture, usability engineering, quality and document management, medical informatics, and basic IT security topics such as confidentiality, integrity, and availability.
CPMS-FL targets early-career professionals or experienced engineers new to medical devices and serves as the prerequisite baseline for CPMS Advanced Level tracks.
CPMS Foundation Level (CPMS-FL) level content
CPMS-FL covers the fundamentals of developing medical software in a regulated context, with baseline knowledge across regulation, standards, engineering, and evidence. Topics include:
Regulatory fundamentals, including when software is a medical device under the EU Medical Device Regulation (MDR), key roles (manufacturer, importer, authorized representative), and the purpose of harmonized standards.
Core standards awareness: ISO 13485, ISO 14971, IEC 62304, IEC 62366-1.
Risk management basics aligned to ISO 14971, including the purpose and typical contents of a risk management file.
Software engineering in a regulated lifecycle (IEC 62304), including requirements and software architecture fundamentals.
Usability engineering basics aligned to IEC 62366-1.
Quality and document management fundamentals, including controlled documentation and audit-ready records.
Medical informatics overview and basic IT security concepts (confidentiality, integrity, availability).