October 27, 2020
THE ORTHOPAEDIC IMPLANT COMPANY AWARDED ISO 13485:2016 CERTIFICATION
Certification Demonstrates OIC’s Commitment to World Class Quality Standards
RENO, Nevada (October 27, 2020) – The Orthopaedic Implant Company (OIC) today announced it has received ISO 13485:2016 certification for Medical Device and Quality Management Systems, which designates that all of OIC’s orthopaedic implants meet the most up-to-date regulatory requirements specific to the medical device industry.
Supervised by Perry Johnson Registrars, Inc. (PJR), OIC underwent a rigorous three-day audit of its quality management system. To receive certification, a company must participate in intense internal audits and pass a two-stage registrar audit conducted by an external party. Certification demonstrates to regulators that high quality standards have been met.
“This ISO certification confirms that value doesn’t mean quality is sacrificed. Our systems and implants are developed, manufactured and delivered in alignment with the highest quality standards but without the exorbitant price tag,” said Todd Martens, VP of Product Development of OIC. “Along with our recently announced One Procedure, One Price™ initiative, this certification is another step towards proving the clinical and economic validity of value-based healthcare.”
ISO 13485:2016 specifies requirements for a quality management system where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life cycle, including design, development, manufacturing, distribution, and servicing of medical devices. Continued certification and registration to ISO 13485 requires accountability, compliance with regulations such as the U.S. Food and Drug Administration (FDA)’s Current Good Manufacturing Practices (CGMP), maintenance of documentation and traceability of products.
About The Orthopaedic Implant Company
The Orthopaedic Implant Company (OIC) is changing the way orthopaedic implants are delivered and priced. OIC creates better value for the implants known and used every day. The company’s dynamic, human-focused strategy begins and ends with prioritizing people, not numbers. The team is comprised of industry experts who bring together decades of combined experience to create change in a healthcare system that must evolve.
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