After The Approval: Perfecting Your Postmarket Surveillance
Maetrics’ Senior Manager, Parminder Kalle, highlights the importance of understanding and correctly implementing PMS mechanisms for manufacturers wishing to introduce or maintain distribution of devices in markets with new postmarket requirements.
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In this new research paper, Maetrics details the $16.5BN competitive market advantage for medtech firms that move quickly to comply with the new European Medical Device Regulation (MDR). The MDR is designed to improve both clinical safety and fair market access for all medtech players, but a rapidly emerging capacity shortage both among Notified […]November 17, 2017
The most important word of the MDSAP acronym is “Single,” because the program is offering an “all-in-one” audit to accommodate multiple legislations. The industry would be well-advised to treat this as a positive change as the collaboration and support amongst the stakeholders will be the most effective and efficient way to implement the Medical […]July 26, 2017
Agreement has finally been reached over the new European Union Medical Device Regulation (MDR) and is expected to come into effect in June 2017. MDR was approved by the European Parliament on April 5, 2017 and was published in the Official Journal of the European Union on 5th May 2017. This new Regulation, whose […]May 24, 2017
Maetrics, the global consultancy firm that provides regulatory, quality, and compliance solutions to the life sciences sector, will attend next month’s Medica trade fair in Düsseldorf (13-16 November 2017). The company will exhibit on Stand F18-5, Hall 16 and will have senior executives available to share their experience and expertise in regulatory affairs in the […]October 26, 2017
UK (September 04, 2017) – Maetrics, a global leader in life science consulting, has appointed Brian Moan to Director of Solutions Delivery in Europe. A highly qualified industry expert and thought leader specializing in Human Factors, Brian has been involved in MHRA working groups to develop industry guidance, has frequently presented around regulatory issues and has developed […]September 19, 2017
Peter Rose, Managing Director for Maetrics operations in Europe, will be speaking at the upcoming RAPS Regulatory Convergence about the new Medical Device Regulation (MDR) in Europe at the National Harbour at the DC Waterfront on Monday 11th September from 3:00PM to 3:45 PM.August 30, 2017
MEDICA is the world’s largest event for the medical sector. For more than 40 years it has been firmly established on every expert’s calendar. There are many reasons why MEDICA is so unique. Firstly, the event is the largest medical trade fair in the world – in 2016 it attracted more than 5,100 exhibitors from 70 countries […]October 3, 2017
Join us as we learn about the newest changes at the FDA since January 1, 2017; hear a panel discuss the challenges and special efforts that are being made in the world of Cyber Security, and listen to some of the newest adventures into Regenerative Medicine being made that will affect many of our companies […]October 3, 2017
Setting the standard on how the industry should connect and exchange ideas, the Generis American Medical Device Summit provides insights and strategies to enhance the professional development of executives involved in the design, development and manufacturing of medical devices. Join the discussion with over 200 of your industry peers as we explore the challenges and […]September 15, 2017