FDA Compliance Manuals
Maetrics is pleased to offer our condensed Medical Device, Pharmaceutical, and Food & Beverage compliance guides for download.
CLINICAL EVALUATION OF MEDICAL DEVICES
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, 2018QUALITY UNDER SCRUTINY IN PHARMACEUTICAL MANUFACTURING
Recent increases in violations of Current Good Manufacturing Practices (the FDA reports the number of warning letters issued to pharmaceutical companies in 2017 remains significantly above 2013 levels) highlights the importance of manufacturers needing to proactively manage their compliance procedures to ensure a higher level of inspection readiness and achieve increased commercial benefits. There […]
April 25, 2018THE NEW EU IN VITRO DIAGNOSTIC DEVICE REGULATION (IVDR)
The European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) came into effect as of May 26th, 2017. The clock is ticking for current Medical Device manufacturers in the European marketplace to develop and implement strategies to be fully compliant. The new In Vitro Diagnostic Regulation (IVDR) is complex and the […]
January 26, 2018New Year, New European Offices
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, 2018Maetrics brings EU Medical Dev...
Peter Rose, Managing Director for Maetrics in Europe will be speaking about the new Medical Device Regulation (MDR) in Europe at the upcoming American Medical Device Summit at the Westin Lombard Yorktown Center, Lombard, IL, on 25 October at 12:35PM. To learn more about AMDS or to register, click here. To read our whitepaper on […]
October 11, 2018A culture of quality called fo...
With the rise of federal regulations and scrutiny for the life science industry, there is now a greater awareness of the risks and weak links that have developed in the quality management parts of leading pharmaceutical organizations. Maetrics, a leading international life science regulatory and compliance consultancy, believes the pharmaceutical industry should consider improving the […]
April 25, 2018
Regulatory process and approval - Liverpool City Region SME workshop
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
MDR Webinar
MDR – the single biggest change to medical device regulations in Europe since CE marking was introduced in 1993 – is less than 18 months from taking effect. If you haven’t begun planning your transition, now is the time to act. It is imperative that medical device manufacturers and other economic operators be proactive and […]
November 27, 2018
IMDMC Annual Conference
Maetrics is pleased to once again be support the IMDMC’s annual conference in November as a sponsor of this key event. The Indiana Medical Device Manufacturers Council (IMDMC) is an association of medical device manufacturers and other associated companies, formed in 1991, to promote the medical device industry. Maetrics has been a long-standing member of the council and regular […]
November 9, 2018