Book of the Year Award

Fantastic news!

Regulatory Affairs Professional Society (RAPS) has congratulated Robert Ginsberg and Mikael Dahlke for their efforts in co-writing Software as a Medical Device as a “publication that is well-written, accurate, relevant, and presents new information that fills a gap in regulatory knowledge on an emerging, cutting-edge, or state-of-the-art topic.” It was selected for the RAPS Book of the Year Award. Robert and Mikael have written the chapter related to: Safety risk management of software.

Congratulations, and thank you Robert and Mikael and the other leading software expert colleagues for your thought leadership and for your commitment to the profession! Your effort to simplify the regulatory complexity for the industry is well appreciated.

The book can be purchased from RAPS, and Robert and Mikael can be reached at and .