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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’ office in Sundbyberg is ISO 13485 certified.

OUR SERVICES

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.

inspiration

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

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Sara Holmgren

Quality & Compliance Manager, Stockholm

Tel +46 72 454 82 29

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Maria Gren

Quality & Compliance Manager, Malmö/Lund

Tel +46 40 691 95 21

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Maria Månsson

Director, innovation and research & Site Manager Hammarby Sjöstad

Tel +46 70 864 43 99

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

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References

  • Pilloxa AB

    Smart support for life-long medication

  • Implantica 

    Implantica launching new standard of care

  • Measurelet 

    The Measuring Toilet

  • QuickCool 

    Portable cooling system for saving lives

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Work at Prevas