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).
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.