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Quality & Regulatory Compliance Life Science

Methods for product development and production are rapidly evolving and requirements are increasingly tougher. Prevas’ services in Quality & Compliance will help you ensure fulfillment of the market’s regulatory requirements and standards. We will give you the guidance you need for achieving the right quality.

With new regulations and legislation, control and traceability are becoming more important in product development and production. This aspect, in combination with the security aspects for connected equipment, is making work with quality increasingly complex. Prevas’ skilled engineers have an in-depth understanding of product development, production and how these relate to one another. At the same time, Prevas’ specialists also have expert knowledge in regulatory requirements and standards, including GMP, GAMP 5, IVDD/IVDR, MDD/MDR, ISO 27000 series, ISO 13485 and ISO 14971. This gives us excellent prerequisites for providing interdisciplinary services and projects in Quality and Compliance.

Prevas is active in many industries and has extensive and solid experience from development in, for example, medical device, pharmaceuticals and food processing, manufacturing and raw material industries, all of which are strictly regulated.

Prevas’ offices in Sundbyberg, Copenhagen and Uppsala are ISO 13485 certified.


Validation, qualification and verification 

Prevas has extensive experience of validation, qualification and verification of computerized systems (e.g. IT systems, production systems and lab systems). Prevas offers to define strategy and support you throughout the entire life cycle – with requirement specification, risk management, purchasing, development, testing and operational implementation, just to mention a few examples.

Quality Management

Prevas helps customers build, develop, strengthen and evaluate quality systems (gap analysis) in compliance with applicable regulatory requirements and standards. We can also help your organization prepare for inspections by regulatory authorities and assist with internal audits or supplier audits.

With our experience of regulatory requirements and standards, we can provide services as Quality Assurance Manager in your organization or your project.

Risk Management

Risk management is always an essential part of our undertakings, and in addition to that, we offer services in risk management based on, for example, ISO 14971 within Life Science and ISO 27000 series standards.

Regulatory Affairs

We can assist you in regulatory affairs, such as product classification, product registration and authority reporting.

We give you our full attention from start to finish in helping you reach your goals. Get in touch and we will fill you in on the details.


Since the beginning in 1985, we’ve joined with our customers in solving tens of thousands of problems – and in most industries.

Explore possibilities we have discovered together with clients.

Read more about what we do.

Organizations and partners

Swedish Medtech, SmiLe, UIC, Medeon Science Park, Medea, Apotekarsocieteten.

Contact us

Robert Tönhardt

Business Unit Manager, Life Science & MedTech Product Development, Prevas AB

Tel +46 8 799 6428


Contact us

Gunilla Grundström

Business Unit Manager Life Science, Malmö, Prevas AB

Tel +46 73 576 41 48


Want to know more? Contact us about what we can do for you.

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  • McNeil AB

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  • Gradientech

    Ultra-fast diagnostics system can save lives and counteract antibiotic resistance

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