We offer expert regulatory consulting and strategic support for companies, laboratories, and organisations involved in advancing in vitro biomarker testing – from research to routine patient care. Our services ensure regulatory compliance and align with the requirements of your target markets – whether that’s Switzerland, the EU, the USA, Brazil, or South Korea. We help accelerate market access and enable the introduction of innovative diagnostics while supporting established diagnostics that meet patient and healthcare needs.
Our support options
We collaborate with manufacturers, research organisations, medical laboratories, and their partners in the fields of in vitro diagnostics and research use. Our services range from expert opinions and strategic workshops to hands-on coaching and formal statements for authorities and other key stakeholders.
Qualification and Classification
Depending on its intended purpose and commercialisation, your product may be qualified as an in vitro diagnostic (IVD), an in-house IVD, a laboratory-developed test (LDT), a Research Use Only (RUO) product, a general laboratory product, or a well-being product.
We evaluate and determine the appropriate regulatory qualification and risk classification.
Your product is accurately positioned within the regulatory landscape.
Effort Assessment
Leveraging our expertise and experience, we identify the regulatory requirements relevant to your organisation and product.
We provide clear estimates of the effort and resources needed to achieve compliance and market access.
This enables you to make informed strategic decisions and communicate effectively with stakeholders.
Claims Alignment
Claims, labeling, and promotional materials must accurately reflect a product’s intended purpose and performance.
We ensure your user communication and marketing language are aligned with the available clinical evidence.
This strengthens both credibility and regulatory compliance.
Roadmap Development
Once your product’s regulatory positioning and market goals are defined, we support the shaping of your strategy. We present the options and help set actionable milestones. Your path to market entry and to meeting target patient needs is clearly mapped and tailored to your organisation’s goals and capabilities.
Why Choose Us?
Experience and Expertise
Our team brings extensive experience in regulatory affairs and quality assurance, gained through years of working with IVD manufacturers, medical laboratories and various other stakeholders.
Interdisciplinary Team
Our interdisciplinary team combines expertise in IVDs, software and cybersecurity, medical writing and clinical studies to provide comprehensive support that ensures your product’s compliance.
Customised Solution
We offer tailored solutions precisely aligned with your needs and objectives, for successful local and international market entry and for meeting the needs of your target patient group.
How can we support you?
Benefit from our regulatory expertise in IVDs. Whether you are launching a new product or addressing compliance issues in an existing one, we guide you towards a clear, reliable path to market access and ongoing patient care.
Alicja Ritz, PhD
Senior Expert IVD
ISS AG, Integrated Scientific Services
Nordring 4A
3013 Bern
Switzerland
Nordring 4A
3013 Bern
Switzerland
©
2026
ISS AG, Integrated Scientific Services