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Manufacturers of drug device combination products have until 26th May 2020 (and until 26th May 2022 for companion diagnostics) to comply with the the EU Medical Device Regulation (MDR) or risk losing European market access. Maetrics’ newest whitepaper details the adaptations and additions MDR pertaining to drug device combination products. The whitepaper looks closely […]June 13, 2019
The MDR has been on the regulatory horizon for a long time, with draft versions published in 2016 and the final version in May 2017. The MDR transition period ends on May 26th 2020 at which point any non-compliant manufacturers will be restricted from selling and distributing their products on the EU market. Any […]May 7, 2019
Every medical device sold into Europe, irrespective of its classification, must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File. Since our last update on CER execution a renewed guidance in the form of MEDDEV 2.7/1 Rev. 4 was released in June 2016. This paper aims to highlight common sources […]September 10, 2018
The Countdown to EU IVDR/MDR Compliance Has Begun May 2019 – Maetrics, a leading international life sciences regulatory and compliance consultancy, has launched a new whitepaper highlighting the critical importance for Class I medical device manufacturers to comply with the EU Medical Device Regulation (MDR). The MDR transition period ends on May 26th 2020 at […]May 21, 2019
January 2019 – Maetrics, a global leader in life sciences consulting, has appointed Elizma Parry to Director of the Global Clinical Practice. A highly qualified industry professional, Elizma is a proven leader with a strong track record of clinical safety, regulatory and quality management experience. She is leading the company’s clinical practice which is dedicated […]January 30, 2019
Maetrics is excited to announce that we are moving to new offices in Nottingham (UK). As the company continues to grow, we remain dedicated to serving our clients and supporting the life science industry with compliance solutions driven by the knowledge, experience and objectivity of our Solutions Delivery team. Effective December 20th 2018 our new […]December 27, 2018
Executive Forum BREXIT will bring some uncertainty to pharma operations in Europe. New product types such as biologics and personalised medicine will increase pressure to develop innovative solutions for factory building and engineering solutions. The Executive Forum will highlight these limitations and also look at how other branches shape innovation. Our programme features top speakers […]February 13, 2019
Peter Rose and Terry Gustafson will be attending this specialist MDR workshop. The aim of the day is to lead delegates through the development of a time-critical action plan for keeping medical devices on the EU market using proven strategies and tactics. At this workshop, delegates will develop: Advanced strategies to effectively work with notified bodies. […]February 13, 2019
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Also covered will be: Medical devices: conformity assessment and the CE mark. How to conform to the legal requirements for placing medical devices […]November 27, 2018