Unmatched achieves ISO 13485 certification and strengthens quality assurances for the healthcare sector
Unmatched has successfully obtained the ISO 13485 certification, the international standard for quality management within the medical sector. This certification confirms that our processes meet the same strict requirements applied to the development of medical devices — offering clear benefits for our partners and customers. After all, patient and resident safety is not optional — it is essential.
“With the ISO 13485 certification, Unmatched continues to build on its ambition to support the healthcare sector with solutions that are not only innovative, but above all safe, reliable, and demonstrably quality-driven.”
What is ISO 13485?
ISO 13485 is the international standard for a quality management system specifically designed for the medical sector. The standard provides a clear and globally recognized framework to meet safety and performance requirements during the development, production, and support of medical solutions. It guarantees consistent quality, accurate documentation, robust risk management, and demonstrable compliance with relevant regulations.
What’s in it for you?
ISO 13485 sets a high bar for risk management, traceability, safety, and consistent quality. This means that every solution delivered by Unmatched is developed within a proven, controlled, and fully documented system. The result: efficient risk management, smooth implementations, and high reliability.
Enhanced patient and resident safety
ISO 13485 embeds safety and performance requirements into every stage of our product development. The standard mandates thorough risk analyses, design controls, and validation procedures — all focused on preventing and mitigating risks.
Regulatory approval becomes easier
Authorities such as the FDA (US), MHRA (UK), and EMA (EU) expect medical devices to be developed within a compliant quality management system. ISO 13485 is often required for CE marking in Europe and for 510(k) or PMA submissions in the United States.
Greater certainty & reliable implementations
Thanks to strict quality standards, we avoid rework, delays, and variations in outcomes.
Traceability and accountability
ISO 13485 requires accurate documentation of design decisions, changes, and test results. This enables fast and effective root-cause analysis and ensures that process inconsistencies are identified and resolved more quickly.
