August 2, 2011 - College Park Industries, a Fraser, Mich.-based manufacturer of prosthetic medical devices for lower limb prosthetic applications, has obtained ISO 13485 quality management system compliance with support from Emergo Group, an Austin, Texas-based medical device regulatory consultancy.
College Park’s current line of Class I prosthetic devices includes brands such as Trustep, Soleus, Velocity and Accent. The firm opted to implement ISO 13485 to lay the groundwork for a robust quality assurance infrastructure in support of company plans to roll out higher-class devices for multiple markets in the future. The eight-month project began in November 2010. Kimberly Light, Director of Product Development at College Park, explains, “We took the Emergo Group quality system procedures, which were prepared especially for College Park, and then worked together to customize them to our specific needs. Throughout the course of the implementation, Emergo Group provided advice and suggestions for improvement, and also assisted with pre-assessment and internal ISO 13485 auditing.”
Julie Powell, Vice President of Quality Assurance at Emergo Group, adds, “Medical device manufacturers seeking to access markets such as Europe, Canada and Japan generally need ISO 13485 certification in place to do so. The fact that College Park decided to seek ISO 13485 certification prior to any new product rollout shows remarkable foresight on their part, and allows them to move quickly on to the next phase of their product development and marketing strategy.”
About College Park Industries
College Park Industries, a lower limb prosthetics company for over 20 years, designs and manufactures high quality, anatomically correct foot and ankle systems. With innovative solutions and precise engineering, CPI remains committed to the research and development of the finest prosthetics for users all over the world. For more information, visit www.college-park.com.
About Emergo Group
Emergo Group is a global medical device consulting firm providing a wide range of services for device registration, QMS compliance, clinical trial management, in-country representation, reimbursement and distributor search consulting.
College Park Industries