Certifying medical devices

The complexity of medical devices continues to evolve with the introduction of security codes, wireless connectivity, increased storage, and compact, interactive touch screens all becoming part of the current landscape. With the intricate and ever changing nature of the field come significant certification challenges.

Medical device systems have to meet regulatory standards, keep patient data safe, and cooperate with other hardware, while simultaneously reducing footprint, energy and of course, manufacturing costs.

The IEC 62304 medical device certification standard

IEC 62304 defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.

To achieve certification to the IEC 62304 medical device standards, initial certification requires review of the quality management system documentation and assessment of life cycle documentation of the relevant software product.

In order to try to shorten development time and cut cost, companies have been known to try to reuse code that is “proven in use”. However, this is known as software of unknown pedigree (SOUP) and must still be considered when evaluating the security, safety and effectiveness of the medical device. With this being the case, developers must come up with ways to validate and verify this software to ensure that it meets the requirements of the regulatory authorities.

The Richland Technologies edge

Richland Technologies has extensive knowledge and proven domain expertise to test and certify medical devices and get them into the hands of customers faster than ever before. Our project proven methods help our clients better manage time and budget restrictions to ensure the right tasks are carried out in the right order and all project objectives are satisfied to schedule.

We continue to refine our approach by using best in class tools which lessen the amount of time spent manually following processes identified in the IEC 62304 medical device certification standards. Implementing such practices helps mitigate the risk of software failure, slashes customer cost and significantly reduces the device’s overall time to approval.