Why is your regulatory data stored in regional silos? Why is there a requirement for inter-departmental data requests? Why does it take 3 days, 3 weeks, 3 months to find what you are looking for? Why must the regulatory team triple check spreadsheets for data accuracy? Why are weekly registration update meetings scheduled throughout your …
Category archives: Economic Operator
Eye of the MDR Storm
The predictions of an apocalyptic melt down of the medical device industry has not (yet) come to fruition
Actor ID v SRN
The MDCG has issued additional guidance for registration of “other” actors in EUDAMED
Importers – Strategic Partners
Medical device manufacturers must provide regulatory teams with the tools and resources to ensure compliant interactions with their supply chain partners.