Maetrics Successfully Hosts Conference in Zurich, Switzerland
Zurich – May 28, 2015 – Maetrics, an international leader in life sciences consulting, successfully hosted its first event in Zurich, Switzerland today. The conference, “The Cost of Non-Compliance – How New Regulation is Re-shaping the Medical Technology Industry,” was made available to an exclusive audience of industry executives.
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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, 2018
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, 2018
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, 2018
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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, 2018
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