I recently came across a great commentary in the August 2021 issue of “Pharma Technology Focus.” The article is titled, “MDR set to transform how MedTech firms approach content management,” written by Barbara Peraltor, Director of Life Science Solutions at Amplexor.
EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746) went into effect in May 2021, after about a year’s delay due to COVID-19. Medical device manufacturers have known about the new regulations for years and have been working to meet these new, more stringent standards.
I’ve had more than one conversation over the past several years about whether pharmaceutical companies were “ready” for structured content. After all, many of the benefits of structured content roll up into one key business need: scale. And scale — the ability to produce a lot of content quickly, accurately,
A few years ago, the EU parliament passed EU Regulation 536/2014. Article 37 mandates that the results of pharmaceutical clinical trials need to be easily read and understood. Having easy-to-read information provides more transparency and accessibility for the general public.