- 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 creator 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.
TBS Reveal™ is intended exclusively for healthcare professionals and is not available for purchase by the general public. TBS Reveal is a Class IIa medical device, CE marked under EU MDR 2017/745 (CE 2460). FDA clearance is pending; TBS Reveal is not available for clinical use in the United States. Manufacturer: Medimaps Group SA, Chemin du Champ-des-Filles 36A, 1228 Plan-les-Ouates, Geneva, Switzerland. Always follow the instructions for use.
TBS Osteo™ is intended exclusively for healthcare professionals and is not available for purchase by the general public. TBS Osteo is a Class IIa medical device, CE marked under EU MDR 2017/745 (CE 2460). TBS Osteo is FDA 510(k) cleared (K243218) for use in the United States. TBS Osteo is included on the Australian Register of Therapeutic Goods (ARTG No. 528950) as "Inovanz Pty Ltd — X-ray system, diagnostic, general-purpose, application program software". Manufacturer: Medimaps Group SA, Chemin du Champ-des-Filles 36A, 1228 Plan-les-Ouates, Geneva, Switzerland. Always follow the instructions for use.