Mr Rose will be bringing his depth of knowledge and experience working with leading medical device companies on the new Medical Device Regulation 2017/745 in Europe
15 October 2018 – Peter Rose, Managing Director for MAETRICS in Europe will be speaking at the upcoming American Medical Device Summit on 25 October at 12.35pm about the new Medical Device Regulation (MDR) in Europe.
With 25 years of experience in the medical device industry, Mr Rose will be bringing his depth of knowledge and experience working with leading medical device companies on the new Medical Device Regulation 2017/745 in Europe. During his presentation, Mr Rose will shed light on the specific changes MDR brings and provide insight on how manufacturers can formulate a strategy to ensure compliance.
The MDR has consolidated two existing legal provisions and replaced both the Medical Device Directive (93/42/EEC) and the Active Implantable Medical Device Directive (90/385/EEC) and is bringing about important changes within the industry.
As a leader in the industry, Mr Rose has been recognized for his expertise on the new MDR and has spoken extensively about its implications. He sits on the ABHI MDR Implementation working group and on the MHRA Medical Device Industry Liaison Group and ABHI Technical Policy Committee.
Peter Rose comments: “The new regulation offers unprecedented change to the European regulatory environment for medical devices. As the clock continues to tick on implementation and deadlines get tighter, I believe it’s important to share as much best practice and knowledge with medical device manufacturers. Any support that the industry can get to help make the transition to the new MDR smoother will help manufacturers remain compliant, enable higher levels of patient safety and allow critical healthcare products to remain on the market for the end user.”
Maetrics, a leading international life sciences consulting firm, has published information on the new MDR to help the industry understand the changes it will bring and their impact. Peter Rose has also written a whitepaper on the topic that is available to download here: New Medical Device Regulation Requirements
The American Medical Device Summit will be held in Lombard Yorktown Center, Lombard, Illinois, October 24–25. If you would like to find out more about the new MDR, contact Maetrics or visit Booth 41 to meet the expert team.
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About Maetrics
Founded in 1984, Maetrics is a global life sciences consulting firm focused exclusively on regulatory, quality, and compliance solutions for Medical Device, Diagnostic, Pharmaceutical and Biotechnology companies. With offices throughout Europe and North America, Maetrics can assist with local, regional, or global compliance needs.
