Working in Partnership with Eurofins Medical Device Auditing Team
Microbira proudly announces its achievement of ISO 13485 certification. Having completed a rigorous audit in collaboration with the Eurofins Medical Device Auditing team and our Regulatory Affairs Manager from BCS Clinical Consulting.
A Significant Regulatory Milestone
ISO 13485:2016 is a globally recognised quality management standard tailored to the medical device sector. Furthermore, it emphasises robust risk management, regulatory compliance, and the effective implementation of quality systems—distinguishing itself by requiring demonstration of effectiveness rather than continuous improvement. Attaining this certification reflects our unwavering commitment to excellence in diagnostics and our readiness to meet stringent global medical device standards.
Working with the Experts at Eurofins
Microbira worked closely with the Eurofins Medical Device Auditing team throughout the certification process. Eurofins-certified auditors guided us through an external audit of our Quality Management System (QMS), reviewing documentation, mitigating non-conformities, and ensuring alignment with regulatory requirements. Their expertise was invaluable in helping us meet the exacting standards demanded by ISO 13485 and in preparing for future regulatory developments.
Strengthening Trust in Microbial Diagnostics
This ISO 13485 certification is a landmark achievement for Microbira. It reinforces our reputation for delivering safe, reliable, and compliant microbial diagnostic solutions. As our flagship platform—MAAP‑IR—gains traction, this certification will enhance confidence among healthcare providers, regulators, and partners, strengthening our ability to make rapid, AI‑driven diagnostics accessible worldwide.
Advancing Global Health Outcomes
Since our founding in 2019, Microbira has been on a mission to transform microbial identification. With MAAP‑IR delivering accurate results in under five minutes, compared to traditional methods that take 24–48 hours.
Now, with ISO 13485 certification, we are better positioned to expand into new markets and further drive positive impact on patient outcomes and healthcare workflows globally.
What This Means for Our Future
Regulatory readiness: Our QMS now meets globally accepted medical device standards, easing future approvals.
Enhanced credibility: The certification underscores our dedication to quality. In addition, it bolsters trust among stakeholders.
Operational excellence: It lays the groundwork for continued refinement of internal processes, empowering us to deliver even higher quality diagnostics.
About Microbira
Founded in 2019, we are revolutionising microorganism identification with our MAAP-IR platform. By harnessing FTIR spectroscopy and AI, we deliver fast, reagent-free, cost-effective diagnostic solutions that drive better clinical outcomes.
Stay connected by following us on LinkedIn for further updates on our innovations, quality achievements, and expansion plans.
