Information for today’s Regulatory Professional
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We invite you to follow our subject matter experts as they share useful information about key industry regulations along with insights about how organizations are improving the efficiency of regulatory operations information management.
Not Amused
Today I attended a very informative webinar hosted by British Standards Institute (BSI) on their interpretation of the medical device regulation requirements under Article 117 for drug device combination products marketing in the European Union from 26 May 2021. My objective for attendance was to confirm my understanding of the Article and obtain an interpretation […]
Who’s Zoomin’ Who
An optimally engineered and collaborative regulatory operations workplace is not a nice to have, but essential for organisational survival and success.
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”.
Thursday Thoughts: Ugly Data
Do you currently support your lead revenue generating, life-enhancing product with a collection of bench studies from 20 years ago? Can you effectively follow the history of the product data from when it was called project Heart to Heart3, then on to Tech4567 and finally PaceMaker Elite Mach 76A with titanium? We all know that […]
Internal Intelligence Supports Change Strategy
Regulatory change strategy may be defined as “the comprehensive elucidation of a project designed to achieve a specific regulatory goal, such as to obtain a new approval or clearance of an amendment.”
