855.554.5BIO info@biopointinc.com

Case studies

medical device


BioPoint’s customized offerings include both strategic leadership and tactical support within the Regulatory, Quality, Clinical, Safety & Surveillance and HEOR / Market Access functions.

MDR Compliance

Our client required a significant overhaul of their safety department in order to adapt to the newest European regulations (2017/745).

Read more…

Device Safety Compliance

Our client was having many QA and Product Safety issues. They needed to identify their internal safety violations, implement a plan to identify and correct the compliance issues, and subsequently train Product Safety Department personnel.

Read more…