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)

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

Events (1)

The role of manufacturers in the healthcare system

Sep 12, 2023 3:00 PM - 3:10 PM | Halle 2

Die Umsetzung von UDI beim Medizintechnik-Unternehmen und die Bedeutung für das Gesundheitswesen

Providers (13)

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.

Hall 2 / E 2133

VC999® Medical

VC999 Medical is a business unit specializing in medical packaging of VC999 Verpackungssysteme AG, a global leading manufacturer of packaging machines for over 45 years. The machines are designed and constructed at the headquarters of the family-owned company in Herisau, Switzerland.

Hall 2 / D 2105

Aptean DACH GmbH

Aptean is one of the world's leading providers of industry-specific software and offers medical technology companies the right business software including ERP, UDI, computer system validation and the corresponding know-how for start-ups, SMEs and mid-sized companies.

Hall 2 / E 2147

avasis AG

avasis has been your competent partner for the implementation of software solutions for the product lifecycle for over 25 years. We are a leading provider of digitization services for small, medium and large companies with a focus on the medical technology and machinery industries.

Hall 2 / C 2083

1MED SA Regulatory & Clinical development

1MED is a leading European Medtech boutique CRO, focused on preclinical, regulatory, clinical development and quality management systems, highly specialized within the medical devices, combination products and IVDs fields.

Hall 2 / A 2023

Bureau Veritas CPS Germany GmbH

Bureau Veritas ist ein global agierendes Unternehmen mit Produktprüfungen, Inspektions- und Klassifikationslösungen. Erfahrene Mitarbeiter unseres Medical Bereichs unterstützen sie aktiv bei der ISO 10993-18: chemische Charakaterisierung, zu CMR Substanzen Analyse und Dampfsterilisationsprozessen.

Hall 2 / A 2036

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.

Hall 2 / E 2133

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.

Hall 2 / D 2111

ERNI Schweiz AG

ERNI steht für Swiss Software Engineering und schafft Mehrwert für Kunden durch die Bereitstellung methodenbasierter Consulting Services, partnerorientierter Technologie-Services und kostenbewusster Delivery-Services auf einer globalen Plattform, die auf einem Schweizer Mindset beruht.

Hall 2 / A 2026