by Henrike Stutzki | Aug 2, 2024 | Case Study, Startups
Case Study | Project with MindAhead UG The digital health startup MindAhead faced the challenge of declaring self-conformity for its risk class 1 product while meeting all regulatory requirements for safety and performance. In addition, the upcoming DiGA study also...
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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