Consulting

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.

TS Quality & Engineering

Hall 1 / A 1018a

Product

AI Empowered Risk Management Tool for Medical Device Compliance

We have developed an innovative tool to streamline ISO 14971 Risk Management compliance for medical device and combination products using AI to accellerate product development and safety

Metecon Schweiz GmbH

Hall 2 / F 2158

Story

"There are many regulatory compliance providers – so why Metecon?"

Simple: Because we don’t just know what needs to be done – we know how to do it. Together. Whether MDR, IVDR, EC-REP, software validation, or clinical evaluation – at Metecon, more than 60 experts from all regulatory disciplines work hand in hand: with expertise, heart, and conviction.

Bookmark 13

Metecon Schweiz GmbH

Hall 2 / F 2158

Software, AI, and Regulatory Affairs with Metecon: Everything from a single source

Medical devices with software components are subject to complex regulatory requirements. At Metecon, we guide you through this complexity – from the software development lifecycle to CE marking, from EN 62304 and EN IEC 81001-5-1 to the AI Act.

Bookmark 2

Metecon Schweiz GmbH

Hall 2 / F 2158

Between Benefit and Burden: How much regulation still makes sense?

Regulations, guidance documents, standards, annexes, specifications…What was once intended as a helpful framework now feels to many manufacturers like an overengineered system full of rules, redundancies, and well(?)‑intentioned details. So what is truly necessary – and what could (finally) go?

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mindsys GmbH

Hall 2 / E 2161

Here's a mistake!

The connection between CAPAs and psychological safety: This article highlights the link between psychological safety and an effective CAPA system in quality management. It emphasises that effective teams are more open about their mistakes.

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mindsys GmbH

Hall 2 / E 2161

Know-How

Welcome on board!

When culture and processes don't fit together, even the best expertise is of no use. This article highlights how the previous corporate cultures of new employees influence current quality management and what this means for companies.

Bookmark 10

Hohenstein Laboratories GmbH & Co.

Hall 2 / A 2032a

Product

Biocompatibility of breathing gas pathways in medical applications

The biological evaluation of medical devices according to ISO 10993 does not adequately address breathing gas pathways. ISO 18562 considers additional specific requirements to enable an appropriate biological assessment of breathing gas pathways.

Rentsch Partner AG

Hall 2 / F 2150

Towards an IP-strategy to protect intellectual property and contribute to business objectives

Do you have an IP strategy in place to adequately protect your company's intellectual property and maximize its value? We protect today's innovation for tomorrow's success.

IFTEST AG

Hall 2 / A 2019

Story

Increasing energy efficiency thanks to smart engineering

Success Story: Iftest AG - High-purity water is essential for applications in medical technology, pharmaceuticals, research and development and food production.

Past events (5)

Swiss Medtech Expo 2025 365

Sep 10, 2025 2:15 PM - 2:25 PM | Halle 2, Symposium

CE – A Gateway to the Global Medtech Market: European Frameworks and the Swiss Reality

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

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

Sep 10, 2025 1:55 PM - 2:05 PM | Halle 2, Symposium

Navigating Changing Waters: How to Keep Your AI-enabled Digital Health Software Compliant

Sep 10, 2025 11:10 AM - 11:25 AM | Halle 2, Symposium

Sustainability in Medtech – Is It Really Necessary?

Sep 9, 2025 10:45 AM - 10:55 AM | Halle 2, Symposium

Top-10 Human Factors takeaways to accelerate your medical device development efforts

Providers (16)

Swiss Medtech Expo 2025 365

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

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.

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.

Hall 2 / A 2019

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

Swiss m4m Center AG

Driven by a passion for patient care, we support you in adopting and implementing 3D printing for innovative medical products—backed by ISO 13485 certification.

Hall 2 / A 2026

Phoenix Mecano Solutions AG

As a solution provider with a uniquely broad product range, Phoenix Mecano Solutions AG is Switzerland's leading specialist in the development and manufacture of components and innovative system solutions in the fields of enclosure, linear and profile technology, as well as production 4.0.

Hall 2 / E 2157

Rentsch Partner AG

We protect innovation today for tomorrow’s success. As a leading Swiss law firm for intellectual property, we safeguard MedTech technologies – from smart devices and diagnostics to software and mechanics.

Hall 2 / F 2150

mindsys GmbH

Jointly achieving the optimum management system in the medical sector - through targeted coaching and individual workshops!

Hall 2 / E 2161

Metecon Schweiz GmbH

Metecon Schweiz GmbH supports medical device and IVD manufacturers as CH-REP and EC-REP for market access in Switzerland and the EU. We guide you through the full regulatory lifecycle – efficient, tailored, and with deep expertise in RA, digitalization, AI, and cybersecurity.

Hall 2 / F 2158