MedTrace Earns ISO 13485 Certification, Meeting Stringent Standards for Medical Devices

  • MedTrace is now ISO 13485 certified for the company’s quality management system in medical devices.
  • The first technical file for the medical devices Patient Kit and Patient Kit Extended has been submitted as class IIa products and is currently under review for CE marking.
  • Patient Kit and Patient Kit Extended are part of MedTrace’s automated manufacturing system for producing, dosing, and injecting 15O-water to patients during PET exams.

Today, MedTrace, a pharma and device company and an innovator in PET diagnostic imaging, announce and celebrate that the company is certified according to the stringent ISO 13485 and thereby recognized for its quality management system in medical devices. The first technical file has already been submitted and is currently under review.

“Receiving the ISO 13485 certification and submitting the first technical file is a great achievement that we have worked towards for several years and the entire MedTrace team is to thank for this. I could not be prouder of what we are able to accomplish together,” says Maja Damby Carøe, senior director, Quality Assurance & Regulatory Affairs at MedTrace.

The enthusiasm is shared by the whole team and COO and U.S. President Rune Wiik Kristensen says:

“Gaining the ISO 13485 certification and submitting the technical file in these times where the EU is transitioning from the Medical Device Directive to the Medical Device Regulation truly demonstrates the company’s impressive operational capabilities, and it cements our ongoing commitment to eliminate uncertainty in diagnostics and improve patient care,” he concludes.

The company ultimately aims to eliminate diagnostic uncertainty via better perfusion imaging using 15O-water as an imaging agent. It has an ongoing phase 3 trial that seeks to evaluate the use of 15O-water PET in diagnosing coronary artery disease (CAD).

The medical devices now under review, Patient Kit and Patient Kit Extended, connect the company’s automated manufacturing system (P3 MT-100) to the patient via a venflon. The automated manufacturing system produces, doses, and injects patients with 15O-water during PET exams. Patient Kit and Patient Kit Extended have been submitted as class IIa products and are currently under review.

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Forward looking statement

This news release by MedTrace Pharma A/S (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. The company offers no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.


Rune Wiik Kristensen
COO and U.S. President
+1 (612) 499-0933