We support you with clarity, expertise and foresight – from the initial concept to successful market approval. Whether it’s quality services, clinical operations, regulatory affairs, global registrations, or specialised consulting in cybersecurity and artificial intelligence, we help you meet regulatory requirements and position your medical devices and in vitro diagnostic medical devices securely and sustainably in international markets.
Do you need support to develop your medical devices and IVDs in compliance with regulations and successfully bring them to global markets?
Our Expertise
Global Registrations
Worldwide registration of medical devices and IVDs. Strategies for entering new markets.
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Quality Services
Development and optimisation of quality management systems and preparation of technical documentation.
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Clinical Operations
Planning, conducting and monitoring clinical investigations for medical devices and performance studies for IVDs.
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Corporate Services
Support with administrative procedures, scientific due diligence, preparation of expert reports and more.
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Digital Solutions
Solutions for cybersecurity and the integration of AI tools into medical devices and manufacturing processes.
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Medical Writing
Preparation of clinical evaluations and performance evaluations according to MDR and IVDR.
View moreOver 11,000 medical devices and IVDs successfully registered globally
This figure demonstrates our extensive experience and strong regulatory expertise. We effectively assist MedTech manufacturers in navigating complex national and international approval processes, ensuring that their medical devices and in vitro diagnostics (IVDs) reach the market while complying with all applicable regulations..
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Testimonials
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Heidi FriesacherHead Global Quality & Regulatory at Belimed AG«ISS AG has effectively supported us in the global registrations of our medical products. For the past 8 years, we have relied on their experienced consulting team, which has been instrumental in successfully registering our products in 88 countries.» -
Christoph BosshardCo-CEO at Oertli Instrumente AG«ISS AG convinced us with its profound expertise in optimizing our quality management and implementing cybersecurity solutions for our medical devices – competent, reliable, and clear.» -
Dr. Armando GisepVP Clinical Research at Icotec AG«ISS AG successfully acts as a CRO for the demanding clinical studies of our class IIb products, prepares clinical evaluations and supports the transition to MDR. Thanks to this "one-stop shop", we have exploited many synergies and are very satisfied with the collaboration. » -
Dr. Christian MünsterHead of Regulatory and Clinical Affairs at Carl ZEISS Meditec AG"Thanks to the good preparation and structured implementation of the project by ISS, the implementation of REGULA™ proved to be extremely productive. The collaboration with ISS was very pleasant and a congenial working atmosphere was created, which contributed massively to the progress of the project." -
Dr. Regina BruggisserHead of RA, Quality and R&D at IVF Hartmann AG«ISS supported us in the processing of the clinical evaluations and the change of the product labelling in the context of MDR. We have received very competent and solution-oriented support. We will also be happy to work with ISS on future projects.» -
Franck BernardStellvertretender Direktor Qualitätsmanagement at Tapernoux S.A.«ISS AG played a key role in helping us convert our technical documentation from MDD to MDR compliance. Thanks to their strong expertise in GAP analysis and their strategic approach, they have significantly simplified a complex process. We can recommend their services without reservation.» -
Aurélie BonFounder & CEO at Red drop LAB.ISS AG provided outstanding hands-on support in helping us navigate the Swissmedic registration process and assess the most efficient regulatory pathway for our products. Their expertise, responsiveness, and pragmatic guidance significantly simplified what could have been a complex process. Thanks to their support, we were able to move forward with clarity and confidence. We highly recommend ISS AG as a trusted regulatory partner.
Upcoming Event
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Swiss MedTech Event 2026MedTech in Recalibration: Staying Ahead in Regulation, AI and the Deal LandscapeSidley, ISS AG and Swiss Medtech invite you to join our annual Swiss MedTech afternoon, bringing together regulators, industry leaders, legal experts and scientific advisors for a focused exchange of insights and perspectives. 2026 marks a pivotal moment for MedTech. Key regulatory frameworks are in transition: MDR and IVDR revisions are advancing, the implementation timeline of the AI Act has been updated, and EU simplification initiatives are reshaping obligations across sustainability, digitalisation and reporting. At the same time, manufacturers are also navigating growing geopolitical and economic uncertainty, including supply chains challenges and rising costs. In Switzerland, developments such as Swissmedic’s proposed fees and swissdamed add further complexity, while increasing M&A activity reflects the shifting regulatory and market landscape. The event provides a platform to discuss current developments, share practical insights and explore strategies to stay ahead in a rapidly evolving landscape. Key topics
Date: August 25, 2026 |
Knowledge & Insights
ISS AG, Integrated Scientific Services
Nordring 4A
3013 Bern
Switzerland
Nordring 4A
3013 Bern
Switzerland
©
2026
ISS AG, Integrated Scientific Services