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.
Los Angeles, CA — February 9, 2026 — Plexāā Ltd., a brand-new Prehab™ 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.
