NuVasive and Zimmer Biomet have become pending subscribers to the MedAccred accreditation program.
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The MedAccred program is the industry-managed approach to ensuring quality through the medical device supply chain, and the accreditation is an assurance that a company’s critical manufacturing processes meet industry consensus requirements.
MedAccred audit requirements are set by its OEM Subscribers, including Baxter, Becton Dickinson, Boston Scientific, Edwards Lifesciences, Medtronic, Philips Healthcare, Roche Diagnostics and Stryker. As Pending Subscribers, NuVasive and Zimmer Biomet have taken the first step toward full Subscriber status.
NuVasive is a spine technology company headquartered in San Diego, CA, with facilities around the world. It specialises in spine technologies, developing better and less invasive surgical treatments. Whitney Ginter, senior manager, supplier quality, quality assurance, NuVasive, said: “As an innovator in this safety-critical industry it’s important that we play our part in driving up quality and contribute to development of new, relevant audit criteria that assure the quality of emerging processes and techniques.”
Zimmer Biomet is a developer of medical implants and robotic technologies, using artificial intelligence and data analytics to improve patient experience and outcomes. Douglas A. Calvelage, quality staff engineer, Zimmer Biomet, said: “We are keen to participate in the MedAccred program to contribute our highly specialised knowledge and expertise to continuously improving quality. We want to partner with supply chain companies to help them meet increasingly exacting requirements as new and better products come on-stream, along with open collaboration with the current medical device organisations which are focused on standardised fixed processes to be followed by their supply chain companies.”
The role of Pending Subscriber lasts one year, with the intention that NuVasive and Zimmer Biomet will then become full Subscribers. As Pending Subscribers, they can attend Subscriber meetings as nonvoting delegates, and receive related communications. They have access to the MedAccred audit criteria and to the MedAccred Qualified Manufacturer List (QML).
Bob Lizewski, vice president, MedAccred welcomed both companies. Lizewski said: “It is great for the industry and the patient population to have more and more highly regarded medical device OEMs contributing to the MedAccred program. In doing so they influence quality improvements that will benefit patients around the world. I look forward to seeing both these innovative, exciting companies become full Subscribers in due course.”