We are proud to announce that Promethean Restorative has achieved ISO 13485 certification. On behalf of Glenn Bowman and Sean Dugan, our team successfully completed its Medical Device Single Audit Program (MDSAP) audit. As a result, Intertek has registered our quality management system as conforming to ISO 13485:2016.
This milestone reflects our ongoing commitment to quality, compliance and continuous improvement. It also marks an important step for a company that designs and manufactures spinal and trauma implants and instruments.
What ISO 13485 Certification Means
ISO 13485:2016 is the international standard for quality management systems in the medical device industry. In short, it sets requirements for the processes a company uses across the life of a medical device, such as design, production and corrective action.
Earning ISO 13485 certification means an independent auditor has reviewed those processes against the standard. For Promethean Restorative, that auditor was Intertek, an MDSAP-recognized auditing organization.
How the MDSAP Audit Works
The Medical Device Single Audit Program lets a recognized auditing organization conduct a single regulatory audit of a manufacturer’s quality management system. In turn, that one audit can satisfy the requirements of several participating regulatory authorities, including the U.S. Food and Drug Administration (FDA).
Our certificate lists United States requirements under 21 CFR 820, 803, 806 and 807 (Subparts A to D). In other words, the audit also covered FDA rules for quality systems, medical device reporting, corrections and removals, and establishment registration.
What Our ISO 13485 Certification Covers
According to the certificate, our management system applies to the design and manufacture of sterile and non-sterile orthopaedic (spinal and trauma) screws. It also applies to the design and manufacture of orthopaedic instruments. Intertek issued the certificate, number 0253370, with an effective date of August 8, 2026.
Thank You to Our Partners and Team
First, a sincere thank-you to Todd Wallenstein and Durably Designed for their critical guidance throughout this process.
We also want to give special recognition to Chase Blackwell, MBA, M.S.; Casey Kindel, CSCP; and Suzan Allen-Koren. Above all, thank you to the entire Promethean Restorative team for the hard work and dedication that made this achievement possible.
Finally, this certification is one part of our wider commitment to quality. To learn more about Promethean Restorative, please contact our team or read more company announcements.
Share this article
