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News: 2020-04-07

Product development for medical devices,
Prevas expands certification in ISO 13485 standard.

Prevas’ office in Uppsala 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 office in Sundbyberg had already been certified according to the standard.

Prevas can provide specialists or full sets of development services, from the idea stage to mass production. This includes quality and regulatory expertise, software, hardware, mechanics, quality assurance and project management resources. Thanks to our specialist teams, Prevas also 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.

“Certification is proof of the expertise we bring to our customers' operations,” says Markus Nässén, who heads Prevas operations in Uppsala. “Our focused work in the heavily regulated development of devices for the life science sector gives us knowledge and experience that benefit our customers. With this certification, we can also provide additional support to companies in the early development phases.”

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 analytical instruments and medical devices,” says Marcus. “Our customers include companies such as Gradientech and Kontigo Care.”

Since 1985, we have seen challenges and discovered opportunities in industries subject to stringent demands. In life science, for example, 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.