With the implementation dates for the new EU Medical Device and IVD regulations looming (May 2020 & May 2022 respectively), companies are having to get their heads around the implications of greater levels of oversight for healthcare technologies where, for example, additional clinical evidence requirements are likely to impose a significant cost.
Furthermore, the EU regulations are only one of a number of different regulatory standards that life science companies need to navigate when selling products globally, with FDA becoming the first accreditation of choice for some new start-up companies. Whilst there are complexities posed by increasing regulation, there are of course opportunities offered through other initiatives, such as the emerging Medical Device Single Audit Program framework.
With so much change occurring in a short amount of time, there has been an overwhelming demand from our member companies for an event which allows companies to learn from each other, share experiences and knowledge they have gained in the practical implementation of global medical device and IVD regulations.
This event is designed to do just that: Providing real life experiences and offering a unique networking opportunity for CEOs and regulatory staff involved in the decision-making process around global medical device and IVD regulations.