• 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. [email protected] www.medtrace.dk
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.
