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.
Have a Question?
Contact us to learn more & find out how Maetrics can solve your regulatory or compliance issues.
One of the first action points for affected organizations will be to monitor developments and assess the level of overlap between the EU and UK regulatory regimes to prevent unnecessary duplication of efforts. As more information becomes available, Maetrics’ new guide provides a list of ten actions that manufacturers can build into their regulatory […]November 23, 2020
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
MONROEVILLE, Pa. In September of 2020, Regulatory and Quality Solutions LLC (R&Q) announced its acquisition of Maetrics LLC. The strength and size of the combined companies deserved new branding, and the new company name RQM+. As RQM+, the two companies – which will continue the strong service offerings previously available through R&Q and Maetrics – […]January 11, 2021
As the medical device industry gears up to implement a new set of requirements following Brexit, Maetrics has released a concise guide summarizing the known requirements so far and priority areas where manufacturers can give their immediate attention. As manufacturers work hard towards compliance with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic […]November 23, 2020
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
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