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News: 2022-07-01

Prevas expands certification in ISO 13485 standard

Prevas’ office in Copenhagen has now also obtained the ISO 13485 certificate. A clear acknowledgement that we deliver development services in full accordance with the high-quality requirements set for medical devices. The offices in Sundbyberg and Uppsala had already been certified according to the standard.

Prevas expands certification in ISO 13485 standard

Prevas can provide full sets of development services, from the idea stage to production. This includes quality and regulatory expertise, software, hardware, mechanics, quality assurance, and project management. Thanks to our specialist teams, Prevas offers turnkey development of medical devices and analytical instruments. To retain our position at the technological forefront, Prevas utilizes a large and rich network of specialists and partners.

“We are now 13485 certified as one of the only development houses in Denmark. Certification is proof of the expertise we bring to our customers' design and development projects,” says Henrik Møller, who heads Prevas operations in Copenhagen. “Our focused work in the heavily regulated development of devices for the life science sector gives us knowledge and experience that benefit our customers.”

Interest is increasing in electronic and communicative care solutions, both among care givers and consumers who want to live long and healthy lives. Our specialists meet both individuals and companies who need development support to realize their innovative ideas for medical devices, eHealth and mHealth, as well as various healthcare solutions. And often for the benefit of both the individual and society at large.

“We have an excellent and long track record when it comes to developing medical devices. With this certificate we can provide additional support to companies in the design and development phases”, says Henrik Møller.

Since 1985, we have seen challenges and discovered opportunities in industries subject to stringent demands. In life science there are requirements for high safety and reliability, as well as regulatory requirements. Certification sets us apart from other suppliers and meets the requirements of our customers.