IEC 62304 -standard
IEC 62304 defines the set of processes for life-cycle management of medical device software.
IEC 62304 defines the set of processes for life-cycle management of medical device software:
- Software development process
- Software maintenance process
- Software risk management process (together with ISO 14971)
- Software configuration management process
- Software problem resolution process
The standard is applicable for all medical devices that include software (driving or influencing) and to softwares that itself are medical devices i.a. Medical device softwares.
IEC 62304 is commonly used together with the quality management system standard ISO 13485 and the risk management standard ISO 14971 for medical devices and fulfills the requirements set in e.g. MDR.
Kasve has extensive experience in planning, development, implementation and management of software development processes that fulfills the IEC 62304 requirements. Kasve also supports customers in creating a requirement fulfilling software development platform and document environment that automatically fulfills the requirements set in the standard.
Looking for a quality expert?
We have helped a number of medicinal device manufacturers, testing and clinical laboratories, and start-ups develop their operations.
IEC 60601 -standard
IEC 60601 is a series of technical standards that describes the requirements for the safety and essential performance of medical electrical equipment.
IEC 62304 -standard
IEC 62304 defines the set of processes for life-cycle management of medical device software.
ISO 13485 -standard
The ISO 13485 standard sets a frame for quality management systems for both medical device manufacturers and other organisations in the chain.