KICVentures Group Successfully Meets ISO 13485 Recertification for its medical device subsidiary
KICventures Group's internal; medical devices R&D subsidiary LESspine Innovations has successfully completed its ISO 13485 Regulatory recertification audit on Tuesday 9-7-2021.
BOSTON, Sept. 10, 2021 /PRNewswire-PRWeb/ -- KICVentures Group Inc., a Boston-based investment firm with a portfolio of leading healthcare technology companies focused on spine surgery, announced that portfolio company LESspine Innovations has successfully completed its ISO 13485 recertification audit.
What is ISO 13485? It is an internationally recognized standard for a Quality Management System ("QMS") for the design and manufacture of Medical Devices. All ISO standards are reviewed and updated every five years. The global standard is mandatory in some countries, and in the U.S. the FDA has proposed a rule which would harmonize U.S. FDA 21 CFR 820 with ISO 13485.
LESspine's recertification effort follows over a decade of commitment to their quality system registration which was first achieved in 2009, the scope of which is the design, manufacturing, and distribution of orthopedic implants and instruments. As in prior audits, this current recertification continued to find substantial compliance with regulations and quality system requirements.
"We are proud of the results of this audit. It is a testament to our team's commitment to compliance and the effective operation of our quality system to have completed this recertification effort with no findings," stated John Sullivan, Vice President of Global Quality and Regulatory Compliance.
This recertification provides another three years of ISO 13485 registration, subject to sustained compliance that will be assessed in standard annual surveillance audits.
About KICVentures
KICVentures is a private investment company founded in 2005 by Harvard-trained Orthopedic Surgeon & Professor Dr. Kingsley R. Chin, who brings unique experience at the intersection of medicine, business, and information technology. KICVentures is equipped with a strong advantage in identifying niche healthcare opportunities. The company is headquartered in Boston, Mass.
Contact info:
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+1.978.232.3900
Media Contact
John Sullivan, KICVentures, (978) 232-3990, [email protected]
SOURCE KICVentures
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