Quality by Design.
Not by Coincidence.

ISO 13485:2016 certified. FDA registered. Documented processes for every repair we perform.

Innovatus Imaging is ISO 13485:2016 certified, the highest standard for quality management systems in medical device repair. That certification means every repair we perform is governed by a documented process, executed by trained and competency-verified technicians, and traceable through our full quality record system.

We only perform repairs on devices for which we have a documented process within our ISO QMS. That is not a limitation. It is a quality guarantee. It means you can trust the outcome because the process was designed to produce it.

For procurement teams building defensible vendor programs, compliance officers evaluating service partners, and clinical engineers who need predictable results, our quality infrastructure is the foundation of every decision to work with Innovatus.

Our Credentials

  • ISO 13485:2016 Certified. Quality management system specific to medical device manufacturing and repair.
  • FDA Registered. Compliant with applicable federal regulations governing medical device manufacturing.
  • Industry’s Longest Warranty. On both ultrasound probe and MRI coil repairs, because we stand behind what leaves our facility.
  • Documented Repair Processes. Every repair performed within a controlled, traceable QMS process.No undocumented workarounds.
  • Competency-Verified Technicians. Training and qualification requirements built into our quality system, not left to assumption.

Certifications are available upon request. Contact us to discuss your organization’s specific compliance requirements.

Contact Our Quality Team