It is with great pleasure that we announce our successful ISO13485 certification – demonstrating our commitment to quality, safety and continuous improvement.

Building a compliant Quality Management System (QMS) from the ground up, now supporting our ISO13485 certified status, is a terrific milestone for any medical device company. It signifies many years of dedication to ‘doing the right things right’.

This would not be possible without the consistent investment and attention to this goal from the outset by our Founders, Dr. Brendan Boland & Gerry Clarke, along with the support of Frank Enright, IncraMed Ltd. from the founding of the business. In more recent years Loci has developed its own internal talented QMS team.

In foreground of the picture is the Loci Quality/Regulatory Manager Anne Gannon and Quality Systems Engineer Teresa Murphy, whose achievements were supported by Niamh Carter (Loci Quality Systems Engineer) and Ger Timoney (QMS Consultant). A most notable mention to John Egan, our VP Technical Operations, and Emily McLucas, Consultant RA/QA, for their leadership in achieving this significant milestone. It takes a company wide effort to achieve ISO13485 certification, and our supportive cross functional team always lead by example!

It is a proud day to celebrate one of the major milestones within the life of a medical device company’s progression. Here’s to many more major milestones ahead for Loci Orthopaedics!