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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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
Navigating Post Market Surveillance Requirements in International Waters and in a Changing Regulatory
In the EU, specifically, it is crucial for manufacturers to review their systems, processes, and procedures for post market surveillance to ensure that they are compliant not only with the increasingly demanding requirements expected in the new Medical Device Regulation, but also with those of the single countries they distribute to. This must-read guide outlines […]June 22, 2016
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
Indianapolis (6/15/17) Maetrics, a global management consulting firm providing life science companies with deep quality, compliance, regulatory solutions to the life sciences industry, recently named Chris Busse as Vice President, Business Development. In this role, Chris will be responsible for further developing our presence in the Western United States and managing key client relationships.June 15, 2017
Companies want an effective Quality Culture, but many experience challenges getting the culture established and sustaining it once they’ve made initial progress. In this session Maetrics will share insights on important elements of a Quality Culture, and help you assess the effectiveness of your company’s current culture. The session will also include discussion on ways […]October 25, 2016
The annual conference sponsored by the largest global organization for the regulation of healthcare and related products.June 12, 2016
The Summit sets the standard on how the industry should connect and exchange ideas.February 5, 2016