In collaboration with Copenhagen HealthTech Hub, Danish Industry, Medicon Valley, Danish Regions, Welfare Tech, Copenhagen Capacity & Medicoindustrien, Reach Media produces a magazine about Healthtech in Denmark, which has today been published and distributed in Børsen. The purpose of the magazine is to raise awareness of Healthtech’s importance to the health sector now and in […]
A working committee group has been working on updating the risk management standard ISO 14971 and a technical report (ISO 24971) to support the risk management process. ISO 14971:2019 was published this month (December 2019), and an updated ISO TR 24971 is expected to be published in a couple of months. What is important […]
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The medical Device Companies – and especially a lot of their Quality/Regulatory Affairs departments – hoped, right until the end, that the updated 13485:2016 standard would be merged with the new 9001:2015 approach and structure. A common approach supporting the entire company and all its processes – internally as well as externally. ISO9001:2015 – […]
Once again, we are scaling up on our task force in Quality Management and Design Control for medical device development. Our new Quality Management System Specialist, Anne Mette, will help us further develop our ISO 13485 certified Quality Management System (QMS). Not only will this benefit our colleagues, our clients who use and adopts our […]
As shown in the graph above, only 31% of all 510(k) applications (Premarket Notifications) goes through the approval process without a request for ‘Additional Information’ (AI) from the US approval authority; U. S. Food and Drug Administration (FDA). This figure clarifies and emphasizes the bureaucratic and often confusing approval process that all medical devices must […]
Marianne is an expert in quality systems – ISO9001, AS9100, the Medical Device Standard ISO13485, including the Special Design Control Process in Medical Device Development and has worked with quality systems in the last 15 years. Most recently for 10 years at Coloplast. Marianne has also worked extensively with validation – processes, clean rooms and […]