Quality Assurance & Regulatory Compliance

In medical technology, quality management is not just a prerequisite for market approval – it is a central part of the product's value. We help you navigate the regulations and standards and support you all the way – from strategy to certification.

We ensure that quality work supports development – ​​not slows it down.

Pauline Tryvall, Quality Manager Prevas

Quality management, quality assurance and regulatory compliance

Developing medical devices requires more than technical expertise. It requires a deep understanding of global regulations and standards, traceability at every stage and quality work that works in practice. We offer specialist services in Quality Assurance (QA) and Regulatory Affairs (RA) – to help you create safe, sustainable and certified products.

We are ISO 13485 certified* and have extensive experience supporting everything from start-ups to established Medtech players. Whether you need a strategy, a complete quality management system or a sounding board in a regulatory complex project, we are here as your partner throughout the entire product lifecycle.

What can we help you with?

We offer a wide range of services in quality management, quality assurance and regulatory compliance, tailored for medical devices and combination products. Our experts have in-depth knowledge of regulations, standards and product development – ​​and can work operationally in projects, as strategic advisors or auditors.

Our experts can take on the role of interim QA manager, QA in development projects, PRRC, or conduct audits and GAP analyses against MDR, IVDR, ISO 13485, etc.

We establish and maintain effective quality management systems – from individual processes to full-scale QMS or electronic QMS. We design the system or process based on your product, market and business – regardless of whether it is a simple management system or a certified QMS for higher risk classes.

We develop regulatory strategies and produce technical documentation - comprehensively or in parts: requirements, risk management, clinical evaluation, biocompatibility, usability, design, verification, software (incl. cybersecurity), etc. We help manage CE marking and registrations and contact with authorities and notified bodies.

We offer training that meets different needs – from tailor-made programs adapted to your business, to open courses in collaboration with our partners. Whether you want to build basic understanding or delve deeper into a specific area, we are here to support your development.

Sharing knowledge is something we value highly. That is why we regularly arrange webinars where we highlight current topics, challenges and opportunities in the industry. It is a chance to gain new insights, ask questions and meet others who are passionate about the same thing.

Want to stay up to date? Feel free to follow us on LinkedIn – where we share knowledge, tips and invitations to our upcoming activities.

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Our teams

Our QA/RA consultants have extensive experience in quality work, regulatory requirements and standards for medical devices (MD) and in-vitro diagnostic (IVD) products, often combined with expertise in software, system security, UX and technology. This gives us a holistic view – from process and documentation to the actual function of the product.

As an ISO 13485-certified organization, we have both the knowledge and the structures to support you in a safe and quality-assured manner. With access to the entire Prevas specialist network in areas such as software, cybersecurity and mechanics, we are a complete partner for medical device development.

*) In Stockholm, Uppsala and Copenhagen, we are ISO 13485 certified.

EN 60601

Product development in Life Science requires solid knowledge of regulations and standards. Prevas specialists in Quality & Regulatory Compliance have extensive experience in testing and evaluation according to the EN 60601 series.
Read more in our witepaper -> pdf, 446.1 kB, opens in new window.

With the right support, MDR and IVDR become enablers – not obstacles.

Johan Sköld, Consultant Manager Medtech QA/RA