Compliance to IEC 62304 – Medical Device Development

IEC 62304 is being adopted by medical device manufacturers whose roductts increasingly rely on software for safe and correct operation. Whether that’s monitoring a patients’ vital statistics, controlling the flow of a drugs dispensed by an infusion pump or sustaining a heart rhythm with a pacemaker, the effect if these devices fail to work properly can be catastrophic.

PRQA TUV SAAR CertificationBy adopting and enforcing a demonstrable commitment to software quality, developers in the medical device market are better positioned to meet legislative and regulatory requirements. In particular, coding standards are “best practice” when developing embedded software, and using static analysis tools to enforce them is crucial to ensuring code quality.

Independent audited by SGS-TÜV SAAR, both PRQA’s QA·C and QA·C++ static analysis tools – when used in combination with our MISRA C Compliance Module and as outlined in the Safety Manual – are certified as “usable in the development of safety related software” for IEC 62304 up to Class C.

Abiomed Achieves IEC 62304 Compliance with QA·C

PRQA has helped a range of medical device manufacturers ensure their software quality, meet the requirements of IEC 62304 and get to market quickly. For example Abiomed used QA·C to reduce the development cycle and eliminate errors that resulted from the manual code reviews they had conducted previously during the development of the AbioCor implantable replacement heart.

Read our Abiomed case study to learn how this company enhanced their development processes using our QA·C static analysis tool.


Download one of our static analysis white papers designed to assist you write high quality code and comply to coding standards such as IEC 62304.