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, 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, 2018Preparing for the new In Vitro...
Maetrics, the global consultancy firm that provides regulatory, quality, and compliance solutions to the life sciences sector, has published a free step-by-step whitepaper to help manufacturers understand the imminent changes and how to comply with the new IVDR that repeals Directive 98/79/EC as well as Commission Decision 2010/227/EU. To get a real handle on the major […]
January 30, 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
American Medical Device Summit (AMDS)
The Generis American Medical Device Summit provides insights and strategies to enhance the professional development of executives involved in the design, innovation and quality of medical devices. Peter Rose, Managing Director Europe, will be sharing the latest insights on MDR in his talk on day 2 of the conference. Visit the Maetrics stand and speak […]
May 17, 2018
The 14th Annual Orthopaedic Manufacturing & Technology Exposition and Conference
Brought to you by ORTHOWORLD, OMTEC is the world’s only conference exclusively serving the global orthopaedic industry. Its mission is to educate, connect and empower the people who build orthopaedic products. Michael Wolf, Director, SD, will be presenting on EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck on Wednesday, June 13, at […]
February 26, 2018