IEC 62304 testing for medical device software

TÜV SÜD reviews quality management system documentation and product-specific life-cycle documentation according to the IEC 62304 standard. This standard covers stand-alone medical software and software embedded into Medical Devices. It builds on the ISO 14971 standard for medical device risk management and requires the application of a Quality Management System (through ISO 13845 or other national quality management regulation, such as US QSR).  

In the EU, IEC 62304 requirements are considered as state-of-the-art for the EU Medical Device Regulation and In-Vitro Diagnostic Medical Device Regulation. Testing against IEC 62304 by an accredited test house demonstrates conformity with these important standard.

In the U.S., the Food and Drug Administration (FDA) recognised the importance of IEC 62304 listing it as a ‘consensus standard’.

Health Canada also requires medical device manufacturers marketing their products in Canada to have their software lifecycle processes according to IEC 62304.

TÜV SÜD issues the IEC 62304 test report based on the review of the QMS documentation in accordance with the IEC 62304 standard, and assessment of life-cycle documentation of the relevant medical software product (stand-alone software or embedded software). 

Our experts have deep knowledge of medical devices and medical device software. Our global network of experts is qualified to perform a wide range of tests. 

Once TÜV SÜD experts complete the assessment with a positive result, you will obtain a test report that demonstrates compliance with the IEC 62304 standard for the product.  

 

Initial certification 
Review of the documentation in accordance with the IEC 62304 standard, and assessment of life-cycle documentation of the relevant medical software product (stand-alone software or embedded software). 

Certificate updates 
Clients can use a change report form to notify the  accredited test house of software changes. Following a change review, the number of the software revision is updated on the test report. Minor bug fixes that do not result in a change in use or a change in the accompanying documentation need not be reported, and thus should not be identified in the revision number on the test report.