C2 Archive - Medical Innovations Incubator GmbH

The role of the Notified Body – An interview with an auditor

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...

From an auditor’s perspective: pros & cons of eQMS

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...

The way to a QMS – How startups overcome this hurdle

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...

The role of the Notified Body – An interview with an auditor

From an auditor’s perspective: pros & cons of eQMS

The way to a QMS – How startups overcome this hurdle

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