• Quality Management & Technical Documentation

Need expert support to establish, enhance, or expand your QMS for Medical Devices and IVDs? Looking for guidance on creating technical documentation for market access?

For over 20 years, we have supported MedTech companies in achieving regulatory compliance in global markets, including the EU, US, UK, Switzerland, and MDSAP countries. Whether you're looking to establish, enhance, or expand your Quality Management System (QMS), our team of experts is ready to assist.

We specialise in building compliant, efficient QMS solutions tailored to meet regulatory requirements and standards like ISO 13485:2016, 21 CFR 820 etc. Our experts in quality, regulatory affairs, clinical, and medical writing support every stage of the product lifecycle, from strategy to QMS implementation and technical documentation, ensuring successful market access and compliance.

Our Expertise

<h2>Quality Management</h2>

Quality Management

Do you need to implement, audit or remediate QMS processes?

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<h2>Technical Documentation</h2>

Technical Documentation

Are you creating, updating or remediating your Technical Documentation?

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Customer Feedback

«ISS AG provided essential support in transitioning our Technical Documentation from MDD to MDR compliance. Their strong expertise in GAP analysis and strategic approach made a complex process manageable. We can highly recommend their services.»

«ISS assumed the role of a Quality Management (QM) officer with us on an interim basis. Thanks to their support, we were able to significantly enhance the quality of our quality management processes in a short time and with minimal effort. What impressed me most was the pragmatic approach taken by the ISS team, which perfectly accounted for the unique requirements of our positioning and size.»

Contact

After completing her master’s degree in Molecular Life Sciences, Deborah Rossier furthered her education and specialised in quality management for medical devices. As a certified ISO 13485:2016 Lead Auditor, she brings valuable expertise to support clients in the strategic development and sustainable enhancement of their quality management systems. With her extensive experience in Regulatory Affairs and successful MDR certification of active Class III products, she is a skilled partner, helping companies meet the highest quality and safety standards.

Deborah Rossier

Deborah Rossier

Head of Quality & Engineering

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