One of StatisticaMedica’s core services is to provide
Statistical Consulting to Optimise Clinical Development Strategies
The value of this service is particularly evident when considering the changing landscape and requirements in the medical device industry in the advent of the new EU Medical Device Regulation (MDR).
In the first of a series of communications about the EU MDR, Gloria Crispino PhD describes in an article published in February 2020 by MedTech Strategist the transition to a more regulated era in the medical device industry, and reasons that the “MDR doesn’t have to strike fear in the hearts and minds of medtech executives.”
In this article, the concerns about the requirements and costs associated with these new regulations are acknowledged, and proven tools that companies can employ to ensure a smoother and less costly transition to the new MDR system are discussed.