FDA Compliance Manuals
Maetrics is pleased to offer our condensed Medical Device, Pharmaceutical, and Food & Beverage compliance guides for download.
Code of Federal Regulations
FDA Inspection Guide
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New responsibilities for Economic Operators will shake up the medical device market, and this new free whitepaper aims to draw attention to the fact that three out of four Economic Operators are now legally and severally liable for devices sold on the market. This is an unprecedented change in regulation, with potential serious consequences […]February 12, 2020
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
Maetrics, a leading international life sciences regulatory and compliance consultancy, has launched a whitepaper explaining the new (and changed) responsibilities for Economic Operators required by the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR). The whitepaper looks at the changes in regulations concerning all four Economic Operator entities, highlighting the […]February 14, 2020
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
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