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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

Service

Innovative packaging services

We attach great importance to meeting the individual needs and requirements of our customers in the best possible way. For this reason, we offer our customers two different options to choose from: "faster" or "tailor-made"

Swiss Medtech Expo 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

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

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

Service

Austria - the Ideal Location for Medtech Companies

From an excellent infrastructure including access to the EU market to one of the best public subsidies for R&D investments, Austria has everything it takes to be a great business location for medtech companies.

Swiss Medtech Expo 2023

Service

Online expertise for pharmaceutical and life sciences industries

As a traditional partner of the pharmaceutical, biotechnology and life sciences industry, we develop expert solutions for connections. The added value of our connector solutions is closely linked to our service: individual analysis and consulting, testing, training, customer service, etc.

Swiss Medtech Expo 2023

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.)

Swiss Medtech Expo 2023

Service

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.

Swiss Medtech Expo 2023

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.

Swiss Medtech Expo 2023

Past events (3)

Miniaturization

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

Risiken und Nebenwirkungen der Miniaturisierung in der Medizintechnik

Event

Oct 14, 2020 12:00 PM - 1:00 PM

Webinar series MDR@noon

Event

Oct 23, 2018 4:30 PM - 9:00 PM

New EU MDR/IVDR Regulation – Solutions for SME

Providers (27)

Health Tech Cluster Switzerland

HTCS provides a network for companies, universities, research institutions and investors. HTCS is personalized - immediate - individual.

Schwyz, Switzerland

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

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

Wirtschaftsförderung Kanton Schaffhausen

Schaffhausen – more return on your investment

Schaffhausen, Switzerland

QUO AG

QUO develops products, processes and technologies. We draw on the know-how of an interdisciplinary team, many years of experience from over 600 cross-industry projects and a large repertoire of methodological competencies.

Glattpark, Switzerland

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

IFTEST AG

Iftest is your partner in the development, industrialisation and contract manufacturing of electronic boards, modules and devices. Expertise, trust and agility form the basis of the collaboration with our customers.

Wettingen, Switzerland

Siemens Digital Industries Software

We offer digitalization solutions for companies in the medical device industry. Our proven, flexible solutions help speed up innovation in medical device development, ensure quality, reduce costs and maintain adherence to ever-changing global regulations, including MDR and FDA compliance.

51063 Köln, Germany

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