ISO 13485:2016 Certification Awarded to Plexāā Ltd.

Plexāā Ltd. has achieved certification to ISO 13485:2016 for medical devices: quality management systems. The certification follows a successful audit conducted by BSI (British Standards Institution) in December.

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,” Plexāā Chief Operating Officer Gaele Lalahy said. “It reinforces our focus on delivering safe and effective Prehab 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 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 United States, United Kingdom, and European Union. 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,” Plexāā Founder/CEO Saahil Mehta, M.D., stated. “By embedding quality, safety, and innovation into every process, we will continue to deliver solutions for patients and clinicians worldwide.” 

Plexāā is a new Prehab tech platform aiming to revolutionize the underserved pre-op phase. By combining preconditioning with its device and prehabilitation, along with its app, the company prepares patients before surgery to improve the patient experience and drive significantly better outcomes.