Press releases 17/06/2026

  • Medimaps has achieved certification under the Medical Device Single Audit Program, an internationally recognized medical device quality management audit program used by participating regulatory authorities in the US, Canada, Brazil, Australia, and Japan. 
  • The certification marks an important milestone in Medimaps’ operational maturity and reinforces confidence among customers, partners, and regulators worldwide. 

GENEVA, SWITZERLAND — June 17, 2026

Medimaps — the creators of TBS (Trabecular Bone Score), the global standard in bone microarchitecture assessment — today announced it has achieved certification under the Medical Device Single Audit Program (MDSAP). 

MDSAP allows a single third-party audit of a medical device manufacturer’s quality management system (QMS) to be used by five participating regulatory authorities: The Therapeutic Goods Administration (Australia), ANVISA (Brazil), Health Canada (Canada), MHLW/PMDA (Japan), and the FDA (United States). 

The certification confirms that Medimaps’ QMS has been audited under a globally recognized program designed to streamline regulatory oversight while maintaining rigorous quality management expectations. Individual product clearances, approvals, and market authorizations remain subject to each country’s applicable regulatory requirements. 

MDSAP supports global regulatory efficiency 

MDSAP enables one audit to address the QMS audit requirements of multiple participating regulatory authorities, helping reduce the complexity of separate national audits. For Medimaps, the certification supports the company’s continued international growth by reinforcing a consistent quality framework across key markets. 

“MDSAP certification reflects the depth of rigour behind everything we do, audited under a program recognized by five of the world’s major medical device regulatory authorities. It is an important milestone for Medimaps and a clear signal that, as we continue to scale internationally, our commitment to quality remains consistent across markets,” said Alexia Pleinecassagne, Regulatory Affairs and Quality Manager at Medimaps. 

What this means for Medimaps’s customers and partners 

For healthcare institutions using Medimaps’ solutions — including TBS Osteo™ for bone microarchitecture assessment and osteoporosis fracture risk evaluation on DXA and TBS Reveal™ for opportunistic bone fragility assessment on routine X-rays — MDSAP certification provides added assurance that these solutions are developed and maintained within a rigorously audited quality management system. 

For distribution partners and resellers operating in MDSAP markets, the certification provides an internationally recognized quality benchmark that can support partner due diligence, procurement discussions, and regulatory documentation across participating jurisdictions. 

About Medimaps 

Medimaps is the creator of TBS™ (Trabecular Bone Score), a global standard in bone microarchitecture assessment. Supported by over 1,600 publications and integrated into clinical guidelines worldwide, TBS is an established complement to bone mineral density (BMD) in fracture risk assessment. 

Founded by medical practitioners and clinical researchers, Medimaps brings together world-class science and a genuine passion for bone health. Following its merger with Radiobotics, an award-winning Danish MedTech company, Medimaps is building a clinical portfolio spanning the MSK care continuum — from TBS Reveal™, opportunistic bone fragility assessment from routine X-rays, to TBS Osteo™, for osteoporosis fracture risk assessment on DXA, to RBfracture™, designed to support emergency and radiology teams with detection of trauma-related findings on X-ray. 

Driven by a shared vision to create an era where healthy bones are the norm, Medimaps is headquartered in Geneva, Switzerland, with offices in Denmark, France and the US. 

Learn more at www.medimaps.ai. 

Media contact 

Elyse Sims, Sr. Director, Global Marketing 
esims@medimapsgroup.com