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Medevise Consulting Achieves ISO13485 Certification

Medevise Consulting Achieves ISO13485 Certification

April 16, 2024

Medevise Consulting, a strategic consultancy specializing in the ophthalmic sector, announced that it has received ISO13485 certification. This certification marks a significant achievement on the company's third anniversary, underscoring its commitment to quality and operational excellence alongside its adeptness in regulatory compliance.

Understanding ISO 13485 and Its Impact

ISO 13485 is an internationally recognized standard that outlines the requirements for a quality management system specific to medical device companies. Achieving this certification signifies that Medevise has implemented comprehensive policies and procedures designed to meet customer and regulatory demands effectively.

Michael Mrochen, a board member at Medevise and co-founder of Allotex, highlighted the significance of this achievement, stating, "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." He further emphasized the value Medevise offers to ophthalmic innovators seeking to enter the European market swiftly and effectively.

Navigating Compliance in the EU Regulatory Environment

In Europe, the medical device regulation (MDR) necessitates ISO13485 certification as a preliminary step towards obtaining a CE mark, validating that a company meets essential regulatory and quality benchmarks. Regular audits are conducted to ensure ongoing compliance with the quality management system (QMS).

Kristine Morrill, Founder & President of Medevise, expressed her pride in the achievement, "This certification demonstrates our organization’s comprehensive commitment to quality." She added, "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."

This milestone not only celebrates Medevise's commitment to maintaining the high standards of its clients but also reinforces its role as a trusted partner in the ophthalmic industry.