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. Download this white paper and discover nine important factors for the successful planning, development and maintenance of a Clinical Evaluation Report (CER).
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. Download this 30 min. webinar and increase your chances of successfully launching your medical device.
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. Download this info sheet and discover all facts & figures about our Israeli expertise.
Which country should I go to for my clinical trial?
Why is it important for manufacturers to focus on the health economics of their device?
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.