Welcome to O'Brien Compliance Management

O’Brien Compliance Management (OBCM) was founded by Frank O’Brien in April 2004 to provide medical device manufacturers with expert consulting, testing, and training services related to the medical electrical equipment safety standard, IEC 60601, and it’s related risk management, usability engineering, and software development life cycle standards, ISO 14971, IEC 62366-1, and IEC 62304. At its peak OBCM had a staff of 8. 

In 2018 the consulting and testing business was sold, and the founder continued with training services.

In May of 2024 the founder provided his last set of training seminars, and retired. A grateful thank you to all the clients and training participants who supported us over the years.

The site is maintained as there are complementary guidance documents available, and a YouTube channel is maintained. Some self paced on-line courses may be offered, but we’ll need to see how this evolves.