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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 system will get an even better experience and easier workday using our improved templates and systematic approach.

Anne Mette will utilize her many years of industry specific experience within QMS requirements, supplier management, internal audit and design control to maintain our ability to comply to MDD93/42/EEC, ISO 13485, ISO14971 and other standards for medical devices and device constituent part of drug-device combination products. Her extensive knowledge feeds into our Design Control activities to ensure that we and our clients meet regulatory requirements and that documentation for the FDA and EMA is prepared thoroughly and correctly. This way, we minimize our clients’ time-to-market and we will hopefully be able to break the trend that only 31% of all 510(k) applications (Premarket Notifications) goes through the approval process without a request for ‘Additional Information’ (AI) from the FDA. The figure below shows and emphasizes the bureaucratic and often confusing approval process that all medical devices must go through prior to market launch – and which can delay the launch significantly.

 

FDA AI requests

 

We believe that we can navigate more safely in a complex and constantly changing world, by working proactively and continuously with both design control and QMS. This contributes to our clients going faster and more smoothly through the FDA approval process – beneficial to project timelines, the project success and our clients’ businesses.

Welcome on team Technolution Anne Mette.

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