STRASBOURG, France—Medevise Consulting, a strategic consultancy that partners with ophthalmic companies to bring innovative products to market, has announced that the company has achieved ISO13485 certification. ISO13485 is a voluntary international standard for developing a quality management system specifically for medical devices, and receiving this certification indicates that a company has developed policies and procedures to meet customer expectations and comply with applicable regulatory requirements. The company noted that this milestone illustrates its commitment to quality and operational efficiency, as well as its expertise in navigating regulatory compliance on behalf of its clients. It was achieved as the company marked its third anniversary.

“The stringent process required to achieve ISO13485 not only establishes trust in Medevise’s client service and operational effectiveness, more importantly it shows that the company functions to the same standards as its clients,” explained Michael Mrochen, Medevise board member and co-founder of Allotex. “Medevise is a valuable partner for innovative ophthalmic companies that want to hit the ground running in Europe.”

The EU medical device regulation (MDR) requires companies to achieve ISO13485 as the first stage of a two-stage process to achieve the CE mark in Europe, a designation signifying that products sold within the European Economic Area meet stringent requirements relative to safety, health and environmental protection. Companies are subjected to annual audits to ensure that they are maintaining their quality management system (QMS).

“This certification demonstrates our organization’s comprehensive commitment to quality,” said Kristine Morrill, founder and president of Medevise. “It also reflects our expertise in supporting and guiding our clients through their own QMS development as they work toward MDR. We know firsthand the regulatory requirements mandated for companies to launch a medical device in the EU. Our team’s insight and experience supports our clients strategically and efficiently in achieving compliance and certification.”