Services

They must comply with all medical regulations in full before the product can even go to market. These are accompanied by several norms, standards and processes like the European Medical Devices Regulation (MDR) and the In-Vitro Diagnostic Devices Regulation (IVDR). In order to succeed, medical technology manufacturers rely heavily on the training and expertise of their staff.

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Posts - that's to be discovered on the topic (63)

Service

Support for International Business Development

SFBC is a public foundation, aiming of supporting innovative companies in Saitama. We have been coordinating business matching and technical collaboration between Saitama companies and German companies for their International Business Development.

MedtecLIVE 2024

Service

Precision through CT scans: Unsurpassed analysis and quality assurance

Discover the future of product development and quality assurance. Our advanced use of CT scans enables detailed analysis of individual parts and assemblies. With precise measurements, non-destructive testing and meaningful quality control, we set the benchmark for highest standards.

MedtecLIVE 2024

Best practice

Risk-based system architecture

In its Appendix I the MDR requires the development of safe, effective medical products. During development, there's a risk of not specifying the product correctly or specifying it to an exaggerated extent. Our systematic approach to a risk-based system architecture provides a remedy and saves costs.

MedtecLIVE 2024

Service

Contract development and “digital prototyping” in the ISO 13485 regulated environment

We support you in developing highly innovative medical products as well as mastering the challenges of the regulatory environment of MDR and ISO 13485. We offer an agile development environment that enables quick reactions to changes during the project.

MedtecLIVE 2024

Service

MedtecLIVE in Stuttgart: Home match for MedicalMountains with perspective

MedicalMountains joint stand sets new record / Daily bus shuttle from Tuttlingen. At the PULSE of medical technology at the MedicalMountains joint stand.

MedtecLIVE 2024

Service

Innovation through cooperation - the Medical Valley ecosystem as a one-stop shop

In the Medical Valley ecosystem, more than 250 members from business, science, healthcare, networks, and politics work together to generate solutions for the healthcare challenges of today and tomorrow.

MedtecLIVE 2024

Service

New Requirements for the Toxicological Risk Assessment of Extractable and Leachable Components

As part of chemical characterization, our experts are ready to assist you with the toxicological assessment of extractable and leachable components following the latest requirements of ISO 10993-17:2023.

MedtecLIVE 2024

Service

Consulting for Medical Devices

Ready for the MDR? We support you with documentation and assessment for your medical devices, covering biocompatibility, sterilization, reprocessing, packaging, and shelf life.

MedtecLIVE 2024

Market & Industry

Services for the CE certification of in-vitro diagnostics

Regulation (EU) 2017/746 on medical devices: The IVDR regulation is the applicable regulatory basis for in-vitro diagnostics (IVD) on the European market.

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Service

Services for the CE certification of medical devices

CE Marking MDR (EU) 2017/745: Regulation (EU) 2017/745 on medical devices (EU Medical Device Regulation) is the medical device law that manufacturers must comply with in order to place medical devices on the European market.

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Providers (34)

seleon GmbH

seleon GmbH has been a leading service partner for medical technology companies in Central Europe for 26 years, focusing on the areas of development, consulting and production.

Heilbronn, Germany

Früh Verpackungstechnik AG

We offer comprehensive services from a single source - in the highest quality, for the best possible protection of products, people and customers. From the development of customized solutions to the production of packaging materials and contract packaging to qualification and documentation.

Fehraltorf, Switzerland

JÜKE Systemtechnik GmbH

JÜKE is an experienced service provider for product development, contract manufacturing and regulatory affairs for companies in the fields of medical technology, analytics, biotechnology, laboratory technology and photonics.

Altenberge, Germany

Psilkon GmbH & Co. KG

Your specialist for everything around: SILICONE! We are a young, dynamic company that specialized in the production and development of silicone molded parts and assemblies.

Motten, Germany

MedtecLIVE

MedtecLIVE 2024 is the leading trade fair in Europe for the development and manufacture of medical technology

Nürnberg, Germany

Corscience GmbH & Co. KG

Defibrillation solutions. Faster. Corscience is the manufacturer-independent partner for defibrillation and monitoring. We offer engineering and consulting services as well as established and customizable solutions. In doing so, we support you in bringing your solutions to market faster.

Erlangen, Germany

3D MicroPrint GmbH

Small in size, but big in detail! 3D MicroPrint GmbH manufactures high-precision micro metal components using Micro Laser Sintering technology. We offer a comprehensive service from product design and prototype development through to series production.

Chemnitz, Germany

Büchler Reinli + Spitzli AG

Wir decken die gesamte Formenbau-Prozesskette von Hochleistungswerkzeugen von der DFM-Analyse, Engineering, Umsetzung im Pilot- bis zum Produktionswerkzeug sowie Formenabnahme und Musterteil-Ausmessungen ab.

Flawil, Switzerland

Lasertec B.V.

Lasertec, your procuction service provider for high-quality laser cutting, laser engraving, laser welding and micro structuring services of highly demanding components.

Barendrecht, Netherlands