Black Friday

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 …

Thursday Thoughts: Webinars

Working from home during lockdown does have some advantages. During the past few weeks I have viewed or participated in a number of virtual discussion sessions and educational webinar presentations across different timezones. I do have to say that the quality of the content and level of professionalism has varied widely. Every day, I receive …

Article 16 and Then Some

Let’s say I am a medical device importer or distributor and have just begun to think about how to incorporate MDR Article 14 and applicable EUDAMED requirements into my day to day processes, when the regulatory manager at manufacturing company AXV asks me about compliance to MDR Article 16 “Cases in which obligations of manufacturers apply to importers, distributors or other persons”.