HIGHLIGHTS

risk management, analysis of applicable regulations and standards, biocompatibility assessment, clinical evaluation
product testing and certification
maint enance of our QMS conform requirements of ISO 13485, EU MDR, FDA’s, QMSR, GMP and more

ensuring compliance with regulations and standards.

Quality is embedded throughout all project stages—from discovery, concept design and product development to production and certification —making us a true one-stop shop for new product introductions in the life sciences sector. We specialize in medical device and equimpent development, ensuring compliance with the applicable regulations and standards, which are essential for developing safe devices.

Navigating Compliance and Certification

expert quality assurance and regulatory affairs for medical devices.

We provide specialized QA/RA services for the medical device and life sciences sectors. Our team is adept at navigating essential regulations, such as the European Medical Device Regulation (EU-MDR) , the European In Vitro Diagnostics Regulation (EU-IVDR ), the U.S. medical device regulation and good manufacturing practice (GMP), ensuring your products meet all compliance requirements.

From the start of each project, we perform a thorough analysis of QA/RA needs to streamline the regulatory process. We can support you in generating and gathering all required evidence, such as risk management, biological assessment and clinical evaluation, to help you achieve certification efficiently. We can assist our customers during the external testing and certification processes by taking an active role in this.

Due to the broad range of products we develop, we are adept to swiftly interpret and implement new standards and regulations, enabling you to stay ahead in a competitive landscape. Our expertise in guiding clients through the certification journey includes medical devices in Europe, the USA and many other regulatory areas , ensuring a smooth path to market for innovative healthcare solutions. With us, you can confidently navigate the regulatory landscape, bringing safe and effective medical devices to patients worldwide.

senior QA/RA Engineer

Iris van Uitert.

“As QA/RA engineers, we are an active part of the project teams. We are involved from quotation to final delivery. In between, we do not only conduct risk management sessions but also assist the engineer with interpreting regulations and standards and their implementation. We find out which regulations and standards apply for the product and support the engineers in interpreting their content. This ensures they can design a product that complies and together we ensure that the necessary documentation for certification is made. We are often closely involved in the certification process, and can be involved with both testing and certification bodies if applicable, depending on the customer’s wishes. In the event that this is up to us, we often have intensive contact with the certifying parties, together with the engineers, or we support the customer in this process.”

Upholding Safety, Performance, and Regulatory Standards

Demcon-wide certification for quality and compliance.

Our quality management system is certified against various standards that reinforce our commitment to quality, safety and performance, including ISO 13485 for our quality management system and ISO 45001 for maintaining a safe work environment. This comprehensive approach guarantees that our products not only fulfill market needs but also enhance patient safety and ensure regulatory compliance in the medical devices and life sciences fields.