How will the new EU General Data Protection Regulation (GDPR) affect my clinical trial?
The European medical regulatory landscape is undergoing its most significant overhaul in years. The eagerly-awaited Medical Device Regulation (MDR), published in May 2017, will bring substantial changes to the way medical device manufacturers bring their devices into the European market.
The UK’s Medicines & Healthcare products Regulatory Agency will continue to recognize CE Marked products for use in the country for a limited time following a ‘no deal’ Brexit scenario, according to new guidance from the agency.
Whether you are a first-time inventor or a large manufacturer, the thrill of bringing a medical device to market is both exhilarating and overwhelming. The development of a successful device not only requires optimized design efforts, but also clinical, regulatory & marketing expertise.
Medical Device Manufacturers benefit from the partnership between genae and MedicSense as we now can provide pre- to post regulatory and quality expertise in addition to clinical trial management and digital health services.
Whether you are a first-time inventor with a novel idea emerging from an unmet need in patient care or a large manufacturer with a rich history in bringing medical devices to the market, the thrill of being at the forefront of an innovative concept is both exhilarating and overwhelming. The development of a successful medical product not only requires optimized engineering design efforts, but also clinical, regulatory, marketing and business expertise.
Artificial intelligence has tremendous potential for the healthcare system. But it’s success requires large quantities of accurate data, among other things.
genae, Experts in Value-driven Science & Technology for the Medical Industries, today announced the acquisition of MedicSense, a Clinical, Regulatory Affairs and Quality Assurance consultancy firm.
Which country should I go to for my clinical trial?