Regulatory Compliance Manuals
Maetrics is pleased to offer our condensed Medical Device, Pharmaceutical, and Food & Beverage compliance guides, as well as the complete text of the EU MDR and IVDR for download.
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This new white paper from leading regulatory and compliance consultancy, Maetrics, highlights how the COVID-19 pandemic is affecting the key business function that safe-guards patient safety: regulatory and quality compliance in the life science sector. Maetrics offers critical insights to an industry under pressure to meet current global healthcare needs, analyzing specific quality and […]August 13, 2020
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
MONROEVILLE, Pa. — Regulatory and Quality Solutions LLC (R&Q)—a leading provider of regulatory and quality consulting services for medical devices, in vitro diagnostic devices (IVDs), and combination products—today announced that it has acquired Maetrics LLC, an international leader in life sciences quality and regulatory consulting. Together, the two organizations form the largest agile and highly scalable […]September 10, 2020
A new white paper from leading regulatory and compliance consultancy, Maetrics, highlights how the COVID-19 pandemic is affecting the key business function that safe-guards patient safety: regulatory and quality compliance in the life science sector. This new paper offers critical insights to an industry under pressure to meet current global healthcare needs, analyzing specific quality […]August 17, 2020
May 2020 – Maetrics, an international leader in life sciences quality and regulatory consulting, has appointed Dr Amie Smirthwaite as Senior Director of the Global Clinical Practice. A clinical and regulatory affairs expert, Amie has over 25 years’ postdoctoral experience in medical devices, spanning new product development, quality and regulatory systems and clinical data evaluation. […]May 18, 2020
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