Regulatory Data Analytics

Regulatory Affairs Analytics Behind every regulatory operations workflow, registration submission, health authority interaction, there lies data ripe for analysis. This data is probably one of the most important resources a life science organisation can possess. Utilising analysis of this regulatory data can help drive change with positive outcomes to support increases in efficiency and revenue …

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 …

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 …

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 …