Medevise Consulting announced that the company has achieved ISO13485 certification, a voluntary international standard for developing a quality management system specifically for medical devices. Receiving ISO13485 certification indicates that a company has developed robust policies and procedures to meet customer expectations and comply with applicable regulatory requirements.

“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,” Michael Mrochen, Medevise board member and co-founder of Allotex, said in a company news release. “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 the two-stage process to achieve CE mark in Europe. Companies are subjected to annual audits to ensure that they are maintained their QMS system.

“This certification demonstrates our organization’s comprehensive commitment to quality,” said Kristine Morrill, Founder & 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 first-hand 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.”
 
Medevise is a strategic consultancy that supports ophthalmic companies in bringing technologies to market. Medevise provides regulatory, clinical, market access, and marketing communication services.