Global Life Sciences regulatory consultancy firm, Maetrics will be launching a new research whitepaper on the European Medical Device Regulation (MDR). The launch will coincide with the company’s attendance at next month’s Medica trade fair in Düsseldorf (13-16 November 2017).
Maetrics works with medical device, diagnostic, pharmaceutical and biotechnology companies to help them meet quality, compliance, and regulatory requirements while remaining competitive and profitable. The company will have senior executives available on its Medica booth, to share their experience and expertise in regulatory affairs in the medical devices sector.
The European Medical Device Regulation (MDR), which officially came into effect in May this year, represents the single largest change to medical device regulations in Europe since CE Marking was introduced in 1993. The Maetrics original research will quantify in clear financial terms the potential market advantage for medtech firms moving quickly to become compliant with the MDR, rather than waiting until the 2020 deadline.
Peter Rose, Managing Director for Europe at Maetrics, said: “We are delighted to exhibit at this year’s Medica and look forward to presenting our extensive knowledge of the medical devices regulatory landscape. There are significant changes taking place that widely affect the industry – including the MDR in Europe, the new international Medical Device Single Audit Program (MDSAP) and ISO 13485:2016.
“Based on our current experience of helping medical device companies navigate these important regulatory changes and meet their obligations, we are ideally positioned to give insight into the practical implications of each regulation and the tactics being employed to achieve seamless compliance.”