• Regulatory Compliance
    for Medical Devices and IVDs

  • Regulatory Compliance for Medical Devices and IVDs

Do you need support to develop your medical devices and IVDs in compliance with regulations and successfully bring them to global markets?

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.

Our Expertise

Global Registrations

Global Registrations

Worldwide registration of medical devices and IVDs. Strategies for entering new markets.

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Quality Services

Quality Services

Development and optimisation of quality management systems and preparation of technical documentation.

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Clinical Operations

Clinical Operations

Planning, conducting and monitoring clinical investigations for medical devices and performance studies for IVDs.

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Corporate Services

Corporate Services

Support with administrative procedures, scientific due diligence, preparation of expert reports and more.

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Digital Solutions

Digital Solutions

Solutions for cybersecurity and the integration of AI tools into medical devices and manufacturing processes.

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Medical Writing

Medical Writing

Preparation of clinical evaluations and performance evaluations according to MDR and IVDR.

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Over 10,000 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

  • «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.»
  • «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.»
  • «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. »
  • "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."
  • «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.»
  • «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.»

At your side every step of the way

Our team has decades of experience in the MedTech and IVD industries. We have a diverse group of experts, including engineers, scientists, and medical professionals, who are ready to support you throughout the entire process – from product development and regulatory approval to a successful market launch. With a clear strategy and hands-on guidance, we provide confidence, direction, and measurable results.
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Knowledge & Insights

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