by Lea Rebholz | May 2, 2024 | C2, Interviews (EN)
Certification of the quality management system and obtaining the CE marking for their product are important milestones for future medical device manufacturers. The Notified Body plays a central role in this process as a testing authority. We spoke to Dietmar...
by Dietmar Schaffarczyk | Jul 17, 2023 | Blogbeitrag (EN), C2
As the healthcare industry continues to grow, it is essential to ensure quality and compliance with regulatory standards. Electronic Quality Management Systems (eQMS) are increasingly being used to manage and maintain quality processes in organizations. This article...
by Lea Rebholz | Jun 22, 2022 | C2, Experience Report
In most cases, distributors of medical devices or in vitro diagnostics need a certified Quality Management System – QMS for short. The development and establishment of QMS pose new challenges, especially for startups. Not only personnel and monetary resources are...
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