Plexāā Ltd. Achieves ISO 13485:2016 Certification for Its Medical Device Quality Management System

Certification reinforces Plexāā’s commitment to quality excellence, ensuring safe, reliable Prehab™ devices and improved patient outcomes. 

FOR IMMEDIATE RELEASE 

Los Angeles, CA — February 9, 2026 — Plexāā Ltd., a brand-new PrehabTM tech platform revolutionizing the underserved pre-op phase, announces it has achieved certification to ISO 13485:2016 — Medical devices: Quality management systems – Requirements for regulatory purposes. This announcement follows a successful audit conducted by BSI (British Standards Institution) in December 2025. The certification became effective on January 16, 2026. 

The certification applies to the company’s Quality Management System (QMS) at its Makerversity, Somerset House office and covers the design, manufacture, and distribution of active, non-implantable medical devices intended to apply heat to the body in pre-operative and post-operative surgical settings. 

“Achieving ISO 13485 certification marks a significant milestone for Plexāā as we grow globally,” said Gaele Lalahy, Chief Operating Officer. “It reinforces our focus on delivering safe and effective PrehabTM solutions that meet the highest international standards for medical device quality, compliance, and patient safety.” 

The design, manufacturing and distribution of Plexāā’s flagship product, BLOOM43, a PrehabTM mobile app and device platform for breast surgery, and other future devices, are fully managed within the ISO 13485:2016 certified system. This ensures regulatory compliance, consistent quality, traceability, and robust risk management throughout each product’s lifecycle. 

ISO 13485:2016 is the globally recognized benchmark for quality management and regulatory compliance in the medical device industry. Achieving this certification underscores Plexāā’s commitment to delivering safe, reliable, and compliant technologies through validated processes, rigorous risk management, and alignment with international standards across the US, UK, and EU. Operating under an ISO 13485:2016 certified Quality Management System (QMS) ensures consistent device performance through structured design controls, complete traceability of components and materials, and robust Corrective and Preventive Action (CAPA), complaint handling, and vigilance processes. This framework not only strengthens regulatory readiness for audits and inspections but also reinforces Plexāā’s ongoing dedication to patient safety, quality, and continuous improvement. 

“Achieving ISO 13485:2016 certification supports our mission to improve patient experience and empower surgical preparation through Supraphysiological Preconditioning™ and Prehab™ technologies, “said Dr Saahil Mehta, MD, FRCS (Plast), Founder and CEO. “By embedding quality, safety, and innovation into every process, we will continue to deliver trusted solutions for patients and clinicians worldwide.” 

About Plexāā Ltd. 
We are a brand-new PrehabTM tech platform revolutionizing the underserved pre-op phase. By combining preconditioning with our device and prehabilitation, with our app, we prepare patients before surgery to improve patient experience and drive significantly better outcomes. Learn more at www.bloom43.com.