Prevas has made it easier and faster to get medical devices approved.
The market for medical devices is growing rapidly. Innovations in the technical world is constantly providing new opportunities for faster diagnosis, as well as better treatment options, more precise examinations, and more precise studies. It is obvious that the requirements placed on medical devices need to be high—after all, it is a matter of people’s lives, and sometimes a little bug in the software or a battery failure can be fatal and cost human lives.
Ideas for life-saving technologies are often devised by enthusiasts with drive and vision. However, they often face significant challenges when they start to realize how much it actually requires to meet the regulatory requirements for medical technology. Prevas’ Life Science specialists have many years of experience in developing and approving medical devices, so they know all about the challenges involved. To make the approval process easier for customers in both financial and planning terms, Prevas is now introducing a series of Medico Template packages to help ensure that preparing and approving medical equipment for launch goes smoothly.
“These templates provide the customer with a thoroughly tried-and-tested starting point,” says Mette Klinting, Senior Project Manager in the Life Science area at Prevas. “They are designed to be adapted to the customer’s chosen quality system and to cover, for example, the documentation of medical software in accordance with the IEC 62304 standard. Another template package supports the start-up and initialization of a Medico project, covering software, electronic, and mechanical design—the starting point for the development and approval of medical technology.”
Prevas already has a number of customers who have benefited from these templates. We strive to play our part in promoting the development of life-saving technology and we hope that this action will make a difference for innovative startups and other businesses with ideas.
The Medico Template packages support the requirements set out in the ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, IEC 60601-1, and IEC 61010-1 standards, and the documentation requirements described in IVDD/IVDR and MDD/MDR.