Regulation

MIK - MDR- & IVDR-Competence Centre

The strict regulations on medical devices (MDR) and in vitro diagnostics (IVDR) often pose major challenges for the industries concerned. As a competence center, MIK offers consulting and development capacities and is oriented towards the needs and requirements of the industry.

KammererMedical Systems GmbH & Co. KG

Hall 2 / B 2060

Know-How

Patient safety takes center stage

We achieve this through consistent quality management across all production steps, from round steel to customized instruments, because quality needs control.

Hohenstein Laboratories GmbH & Co.

Hall 2 / A 2032a

Product

Testing of medical devices – we provide you with neutral proof of efficacy and safety of your product

When used properly, your medical device must not pose any avoidable risks to patients, users or third parties. As the manufacturer or your authorised representative, you are responsible for ensuring this.

Hall 2 / Gemeinschaftszone

MedicalMountains GmbH

News

Let's Connect!

News blog, social media, podcast, newsletter /// MedicalMountains uses various communication channels to inform the cluster about offers and services.

Testo Industrial Services AG

Hall 2 / A 2004

Know-How

Seminars with a practical focus

Are you looking for a high-quality training program on calibration, test equipment management, qualification, and validation? We offer specialized training with a strong practical focus, and our instructors are experts in their fields.

majesty GmbH

Hall 2 / C 2092

Product

Efficient Software Validation According to MDR

With majesty’s validation module, medical technology companies maintain full control over their ERP software at all times – MDR- and ISO 13485-compliant, time-saving, and audit-proof.

Testo Industrial Services AG

Hall 2 / A 2004

On-Site Calibration

Whether in the laboratory, cleanroom, or production: Our specialists carry out calibrations directly on-site at your location – efficiently, traceably, and in compliance with standards. This way, you save time, avoid downtime, and remain audit-ready – without the need to send in your equipment.

Grossenbacher Systeme AG

Hall 2 / E 2146

Device development: innovation and compliance with standards

Innovative and standards-compliant device development for medical technology: At Grossenbacher Systeme, we combine state-of-the-art technologies with a systematic development process to create safe, regulatory-compliant medical devices.

Grossenbacher Systeme AG

Hall 2 / E 2146

Production: Quality assurance and reliability

At Grossenbacher Systeme, we guarantee the highest quality and reliability in the production of medical electronics. From assemblies to complete devices – always in compliance with GMP, ISO 13485, and FDA standards. For safe, durable medical technology solutions.

EXCO Consulting GmbH

Hall 2 / D 2113

Regulatory-compliant qualification of systems and equipment

In the pharmaceutical industry, medical technology and in the clinical environment, the qualification of systems and equipment is a central component of GxP requirements.

Sep 10, 2025 2:05 PM - 2:15 PM | Halle 2, Symposium

Events (2)

Swiss Medtech Expo 2025 365

Presentation

Regulation meets corporate culture: How management systems in medical technology can be designed effectively

Sep 10, 2025 2:30 PM - 3:00 PM | Halle 2, Lounge

Network event

Meet the speakers: Clinical Integration & Regulatory

Providers (10)

Swiss Medtech Expo 2025 365

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 2113

NMI Naturwissenschaftliches und Medizinisches Institut an der Universität Tübingen

The NMI is a non-university research institution. We conduct application-oriented research in the bio- and material sciences and have an interdisciplinary range of expertise for R&D and service offerings for the healthcare industry, vehicle, machine and tool construction.

Hall 2 / B 2066

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.

Grossenbacher Systeme AG

Electronics for life - For decades, Grossenbacher Systeme has been producing sophisticated products for well-known companies in the field of GMP, ISO 13485 and FDA. We are your competent and experienced contact partner for products up to Class IIb.

Hall 2 / E 2146

MedicalMountains GmbH

The MedicalMountains cluster offers a versatile competence network for technology transfer. The cooperation and cross-fertilisation with regional, national and international partners provides SME in particular with an important knowledge and technology advantage in Germany as a medtech hotspot.

Hall 2 / Gemeinschaftszone

Testo Industrial Services AG

Testo Industrial Services AG is a leading service provider company in the field of calibration, qualification, validation as well as test equipment management. Worldwide unique are the laboratories which are accredited for more than 200 calibration procedures.

Hall 2 / A 2004

Hohenstein Laboratories GmbH & Co.

Hohenstein is a family-owned company with more than 75 years of experience. Hohenstein's testing spectrum covers softlines (textile materials), hardlines (consumer goods made of solid materials) and medical devices.

Hall 2 / A 2032a

KammererMedical Systems GmbH & Co. KG

Kammerer Medical Group - Excellence meets innovation The Kammerer Medical Group is your expert for the development and manufacture of high-quality surgical instruments and instrument sets for orthopaedics, traumatology and spinal surgery.

Hall 2 / B 2060

majesty GmbH

More time for your core business: Majesty, the ERP software for medical technology

Hall 2 / C 2092