Medevise Consulting Achieves ISO13485 Certification

Milestone represents company’s commitment to operating at the same high standards as its clients

Strasbourg, FR - April 11, 2024 - Medevise Consulting, a strategic consultancy that partners with ophthalmic companies to bring innovative products to market, announced today that the company has achieved ISO13485 certification. This milestone illustrates the company’s 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.

ISO 13485 is 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,” 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 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.”

About Medevise Consulting

Medevise is a strategic consultancy that supports ophthalmic companies in bringing innovative technologies to market. With a senior-level, global team, Medevise provides regulatory, clinical, market access, and marketing communication services all in one place with unparalleled insight, resources and a network built up over decades of experience. Medevise is driven to ensure the best innovation from medical device companies gets into the hands of ophthalmologists to improve patient experience and outcomes. Learn more at www.medevise-consulting.com.

About Medevise Launchpad

Medevise Launchpad is a commercialization solution for medical companies seeking to launch in Europe. This incubator model streamlines the go-to-market process, immediately placing experienced leadership along with expert resources to quickly and efficiently develop a commercialization roadmap, assess market opportunities, connect with a targeted KOL network, drive the CE mark process, develop a go-to-market strategy, and tackle reimbursement across multiple markets. Launchpad enables companies to hit the ground running, significantly shortening their go-to-market timeline and pinpointing the optimal strategies for success with expert guidance and support.

Contact:

Heather Ukstins, Marketing Manager

heather@medevise-consulting.com

+33 (0) 3 88 30 88 11