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April 2020

Inspire for Sleep Apnea Implant – From Circuit Board Design to Volume Manufacturing

By |2020-05-17T15:59:49+02:00April 22nd, 2020|Non classé, Testimonial|

Inspire for Sleep Apnea Implant – From Circuit Board Design to Volume Manufacturing

Inspire Medical Systems, Inc. is a medical technology company focused on the development and commercialization of an innovative solution for patients with obstructive sleep apnea (OSA). Inspire has developed the first and only FDA-approved neurostimulation device that provides a safe and effective treatment […]

October 2019

21 CFR 820, ISO 13485:2016 and MDR – Are you prepared for the changes ahead?

By |2019-10-24T15:59:04+02:00October 24th, 2019|Medical Device, Non classé, Quality|

Medical device manufacturing and marketing in the U.S.A. is regulated by the FDA. Medical device manufacturers must register with the FDA and produce their products with a Quality System that meets the FDA Quality System Regulation and more precisely with the 21 CFR 820. Compliance with regulations is crucial and requires an investment of both […]

September 2019

Supporting our Customers with the new MDR

By |2019-09-12T14:55:26+02:00September 12th, 2019|Non classé|

The Medical Device Regulation (MDR) will replace the MDD on 26 May 2020. Medical device legal manufacturers are now in various stages of addressing the many changes implied by the new European Regulation. Main changes are product scope expansion, reclassification of devices, more rigorous clinical evidence, recertification of currently approved devices and the use of […]

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