Regulation

The European Medical Device Regulation (MDR), which came into force in 2017, has been in effect since 26 May 2021. On account of the current political circumstances, Swiss medtech companies are faced with additional challenges when it comes to implementation. That's why it's important to keep an eye on the latest developments.

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Posts - that's to be discovered on the topic (23)

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EXCO Consulting GmbH Hall 2 / D 2111
Service

Regulatory Consulting and Approval

As experts for regulatory requirements in the pharmaceutical, medical technology, life sciences, chemical, food and Industry 4.0 sectors, we ensure that you are compliant with regulatory requirements for your project right from the start.

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epmodex AG Hall 2 / E 2133
Service

MDR Readiness: We help you to get there!

Since 26.05.2021, the Medical Devices Regulation is fully applicable. Therefore, all processes related to design, industrialization, manufacturing and market surveillance must be aligned with the quality management system, which must be compatible with ISO 13485:2016 and/or USA QSR.

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Matrix Requirements GmbH Hall 2 / B 2062
Product

Supercharge product development

Get more products out the door by combining existing items from existing projects for reuse in other projects. Compose enables you to include and/or copy items (reuse items) and maintain traceability from the source project in target project(s).

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ERNI Schweiz AG Hall 2 / A 2026
Best Practice

Testing automation in MedTech

Essential for all projects, software testing ensures high-quality, reliable products. A professional process reflects commitment to quality, adhering to guidelines for functional, stable, secure systems.

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TS Quality & Engineering Hall 2 / E 2133
Service

510(k) Submission Support for Medical Devices

MDR is a great burden for all Medical Device Manufacturer. We suggest in many cases prioritizing a US FDA submission. We can assist in the whole process. Write to info@tsquality.ch for immediate assistance.

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TS Quality & Engineering Hall 2 / E 2133
Service

Get ready for MDR Transition now!

Trust the experts! We provide Certified Medical Device Consulting Services since 2010. We have developed a consolidated method for achieving MDR transition smoothly.

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Matrix Requirements GmbH Hall 2 / B 2062
News

Empowering the Future of Medical Device Development with You

A transformation that centers around YOU, our invaluable customers and those we’re yet to meet! At Matrix Requirements, we strive to push the boundaries of quality and excellence for Medical Device businesses.

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TS Quality & Engineering Hall 2 / E 2133
Product

E-IFU Smart Solutions for Medical Device & Pharma

We provide an innovative tool to manage your IFU digitally and in full compliance with MDR/IVDR regulation for your medical device and in vitro diagnostic devices. This will result in huge savings and burden reduction for your company.

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Axians IT Services AG Hall 2 / A 2017
Product

We help you to get your Software GxP-Compliant

Multiple Skills to support and concepts to support your GxP-Compliance. Services tailored to your needs. Best knowledge & experience to achieve your goal.

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avasis AG Hall 2 / C 2083
Service

Industry-specific solutions for digitization

avasis has been serving customers in medical technology for many years. Based on the long experience of the team as well as the experience from various customer projects, a clear focus on this industry has been developed.

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