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Regulation

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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.

Georg Langbehn
Visa Suomi
Irene Reis
Michel Milionis
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Posts - that's to be discovered on the topic (58)

Logo teltec systems ag
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!
Logo TS Quality & Engineering
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
Logo Eurofins Electric & Electronic Product Testing AG
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
Logo Axians IT Services AG
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
Logo Axians IT Services AG
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
Logo Matrix Requirements GmbH
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
Logo Matrix Requirements GmbH
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
Logo Matrix Requirements GmbH
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
Logo 1MED SA Regulatory & Clinical development
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
Logo Bureau Veritas CPS Germany GmbH
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

Providers (21)

Logo SAQ-QUALICON AG

SAQ-QUALICON AG

In the heart of Switzerland, on the pulse of medical technology, we offer specialists as well as generalists in the field of quality management and regulatory requirements a comprehensive range of training and education

Olten, Switzerland

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Logo TS Quality & Engineering

TS Quality & Engineering

TS Quality & Engineering is a ISO 13485 certified company. We offer Medical Device Consulting Services and solutions aimed at facilitating, speeding up and support design, validation, regulatory and quality control process. We can follow the design and development of a new product at all stages.

Zug, Switzerland

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Logo RMS Foundation

RMS Foundation

The RMS Foundation is an independent service laboratory and research institute. The range of services offered by this non-profit organization includes material testing, chemical analysis, advisory services, training as well as technology transfer.

Bettlach, Switzerland

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Logo Aligned AG

Aligned AG

Spending too much time on design documentation and traceability? We can help! Develop medical devices smarter and faster with Aligned Elements.

Zürich, Switzerland

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Logo epmodex AG

epmodex AG

We are your leading partner for development, manufacturing and registration of medical and industrial products in high-end applications. Whether prototypes or finished products in small- and large series: epmodex stands for highest precision, optimal solutions and a reliable partnership.

Dübendorf, Switzerland

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Logo EXCO Consulting GmbH

EXCO Consulting GmbH

EXCO is a globally active technology service provider that delivers custom-made project support services from one convenient source. The company's portfolio includes consulting services, project management and the implementation of ready-to-use solutions in product, laboratory and production.

Root-Längenbold, Switzerland

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Logo Swiss Medtech Expo

Swiss Medtech Expo

Swiss Medtech Expo is the trade fair for Europe's third-largest medtech market. With a practical focus on novel designs, materials, technologies and processes, the spotlight is on how integration and development of new applications leads to innovations in the medtech industry.

Luzern, Switzerland

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Logo Debiotech SA

Debiotech SA

Debiotech is an ISO13485 certified company, active in the development of innovative medical devices, with over 30 years of experience and know-how.

Lausanne, Switzerland

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Logo TRUMPF Schweiz AG

TRUMPF Schweiz AG

TRUMPF lasers and customized process solutions provide high-precision components, e.g. for medical technology – as diverse as your needs are.

Baar, Switzerland

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