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 (58)

teltec systems ag April 10, 2024
Showcase

Revolutionary micro-markings for dental implants

Discover how tiny 2D codes are changing the game for manufacturers and patients: Magnifying glass-clear micro-markings on dental implants enable secure traceability and perfect protection against counterfeiting. Learn more about it here!

TS Quality & Engineering September 11, 2023
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.

Swiss Medtech Expo 2023

Eurofins Electric & Electronic Product Testing AG August 22, 2023
Service

Did you know that IEC 60601-1-2 Ed. 4 was replaced by IEC 60601-1-2 Ed. 4.1?

Acceptance of previous edition for new registrations will expire by the end of this year in Europe and USA. Keep certificates of your product updated to the latest edition and avoid any complications with validity and new registrations! Contact us now to ensure that your certificates are up-to-date.

Swiss Medtech Expo 2023

Axians IT Services AG August 22, 2023
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.

Swiss Medtech Expo 2023

Axians IT Services AG August 22, 2023
Service

Security for Industry

Axians your trusted partner for IT & OT Cybersecurity & Compliance! We create tailored concept's and managed services for the regulated IT Environment.

Swiss Medtech Expo 2023

Matrix Requirements GmbH August 14, 2023
Best Practice

The power of our innovative customers

We're excited to share the successes of our customers & to be there to help you as you improve the way you bring safer, faster medical devices to market.

Swiss Medtech Expo 2023

Matrix Requirements GmbH August 14, 2023
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).

Swiss Medtech Expo 2023

Matrix Requirements GmbH August 14, 2023
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.

Swiss Medtech Expo 2023

1MED SA Regulatory & Clinical development August 8, 2023
Know-How

How to run a robust Risk management Process to ensure the safety and the effectiveness of your medical devices according

1MED SA stands ready to provide reliable support to your Company in the preparation and periodical update of the Risk Management File of your products. Contact us to receive more info.

Swiss Medtech Expo 2023

Bureau Veritas CPS Germany GmbH July 31, 2023
Service

ISO 10993: Biocompatibility

The requirements for an ISO 14971 risk management in the biological assessment of medical devices have significantly changed. We would be pleased to support you as experts in ISO 10993-18: "chemical characterization" in meeting the new challenges.

Swiss Medtech Expo 2023

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