Consulting

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Posts - that's to be discovered on the topic (19)

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.

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.

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.

Service

Chemical characterization of materials according to ISO 10993-18

The assessment of the biocompatibility of a medical device is carried out in accordance with the ISO 10993-18 standard. The FILAB laboratory is ISO 17025 accredited by COFRAC for chemical characterization of materials in accordance with ISO 10993-18.

Service

CMR related substances - targeted analysis

The usage of CMR substances is strictly restricted and should be avoided whenever possible! Our innovative and compact method enabling you to gain confidence about your materials meeting the requirements (in time and cost-effective manner.)

Product

Unyvero A30 RQ (Curetis GmbH)

The new, smaller and faster Unyvero A30 RQ (Curetis GmbH) is a mid-plex system designed to provide rapid quantitative results for a select host of critical targets.

Service

Medical technology planning

We support clients, architects and planners with our know-how in the planning of medical technology systems and equipment. From feasibility studies, to rough planning in the design phase, to execution planning, supplier support, quality assurance during construction and commissioning.

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Bureau Veritas Medical Device Analyses

Bureau Veritas is a global company providing product testing, inspection and classification services. Our Medical professionals actively support you in ISO 10993-18: chemical characterization, CMR substance analysis and steam sterilization.

Events (2)

The role of manufacturers in the healthcare system

Sep 12, 2023 3:55 PM - 4:00 PM | Halle 2

Österreich – Ihr einfacher Zugang zum EU-Binnenmarkt

Miniaturization

Sep 12, 2023 11:35 AM - 11:55 AM | Halle 2

Risiken und Nebenwirkungen der Miniaturisierung in der Medizintechnik

Providers (16)

TRUMPF Schweiz AG

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

Hall 2 / D 2101

Stäubli AG

Stäubli is a mechatronics solutions provider with three dedicated activities: Connectors, Robotics and Textile, serving customers who want to increase their productivity in many industrial sectors. With a global workforce of over 5000. Originally founded in 1892 as a small workshop in Horgen/Zurich.

Hall 2 / F 2140

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.

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

Helbling Technik

Innovation, together we do it

Hall 2 / C 2076a

Ruetschi Technology AG

Als Lieferant, Contract Manufacturer oder Legal Manufacturer unterstützen wir unsere anspruchsvollen Kunden in der Entwicklung und Herstellung von hochwertigen Medizinprodukten.

Hall 2 / B 2046

DMT Produktentwicklung GmbH

Since 1994 we have been developing product solutions for medical technology and the life science/analytical measurement technology sector. As independent and certified development partner working in interdisciplinary teams, we take responsibility for a successful implementation.

Hall 2 / E 2143

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

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