With our expertise in the field of medical devices, we offer dependable expert opinions for a diverse range of stakeholders, including courts, law firms, authorities, and notified bodies.
Diverse Areas of Application
With our expertise in the field of medical devices, we offer dependable expert opinions for a diverse range of stakeholders, including courts, law firms, authorities, and notified bodies.
Qualification
Evaluation of whether the product qualifies as a medical device under legal requirements.
Classification
Assignment of the medical device to the correct risk class under legal requirements.
Technical Documentation
Review of the completeness and compliance of the technical documentation.
Clinical Validity
Analysis and confirmation of clinical effectiveness and safety based on state-of-the-art clinical studies.
Why Choose Us?
Each expert opinion is tailored to the client's specific requirements. We work closely with our clients to ensure all relevant information is considered.
Experience and Expertise
Our team has many years of experience preparing expert opinions for various stakeholders.
Interdisciplinary Team
Experienced experts with in-depth knowledge in various areas of the medical device industry form an interdisciplinary team.
Reliability
Our commitment to clear communication and timely delivery ensures that you are informed throughout the process, providing peace of mind and reliability.
How can we support you?
Do you need an expert opinion or further information? We are happy to assist you.
Bernhard Bichsel
Co-CEO
Kaspar Gerber
Senior Regulatory Affairs Manager
©
2025
ISS AG, Integrated Scientific Services