Medical devices industry regulation opportunity

By Markus Frei

As of May 26, 2021, the EU’s Medical Device Regulation (MDR 2017/745) will replace the previous MDD and AIMD directives. This involves numerous changes in terms of products, documentation, approval and storage that every medical device manufacturer must comply with. How can manufacturers turn this challenge into an opportunity?

The basic safety and performance requirements for medical devices have increased – as have those for the accompanying information. Changes in classification and approval and the doubling of the retention period to 10 years create additional work and expense. Increasing variants, miniaturization and product complexity make this a challenge. Many manufacturers must comply with multiple regulations such as FDA and 510K at the same time.

Distributed development documents and Excel checklists are not the right tools to address these challenges. Instead, how beneficial would it be to replace them quickly and easily with guided processes in an integrated environment in a solution that supports all steps from the definition of user needs through the phases of product development to the collected output of documentation?

In this way, all development disciplines could define and track the complete workload, responsibilities and timeline for approval. The Teamcenter Medical Device Solution developed by avasis combines project management and documentation. It extends the leading PLM solution Teamcenter which is part of the Xceleratorâ„¢ portfolio, the comprehensive and integrated portfolio of software from Siemens Digital Industries Software. With it, you turn the challenge into an opportunity for the entire company! Contact avasis for more information.

Markus Frei is the founder and key account manager at avasis who has been driving digitalisation for small, medium and large enterprises with his deep understanding of the industry for almost 25 years. He supports our customers with the help of digital solutions to increase efficiency and achieve further competitive advantages.

Avasis has offices in Switzerland and Germany and is an Expert Partner specializing in Teamcenter and PLM software implementations. It is a leading provider for digitalisation for small, medium and large enterprises in the medical technology industry and offers consulting, implementation and support service\s for Teamcenter, Polarion, NX solutions and its own developments.

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This article first appeared on the Siemens Digital Industries Software blog at