We've passed the SGS Notified Body EU MDR Stage 2 QMS transition audit

We are extremely proud to announce that Keeler Ltd has successfully passed the SGS Notified Body EU MDR Stage 2 QMS transition audit.

As a result, SGS has granted us the QMS EU MDR endorsement. This significant achievement ensures that we can continue selling our products in major European markets.

Keeler Ltd has been well-established under the Medical Devices Directive (MDD). However, the new Medical Device Regulation (MDR) requirements, which came into effect in 2021, necessitate that all activities from device conception and design, manufacturing, marketing, to post-market surveillance are now governed by the MDR. Key compliance requirements include:

• Designing and manufacturing medical devices in accordance with satisfying the MDR requirements.
• Meeting the General Safety and Performance requirements as outlined in Annex I of the MDR.
• Conducting thorough clinical evaluations for all devices.
• Maintaining current and comprehensive technical documentation.
• Ensuring access to a Person Responsible for Regulatory Compliance (PRRC).
• Implementing a robust Quality Management System (QMS).?

We are pleased to report that Keeler Ltd has met the current MDR stage requirements.

We extend our heartfelt thanks to all team members who contributed to the seamless execution of this audit, including Arminder Purewal , Gavin Colley , Sonia Bargotta , Richard French , Karrthik Manoharan , Nadeyne Williams , and Nazanin Vahid . Their dedication, attention to detail, professionalism, and commitment have been instrumental in ensuring our success.

We remain focused on maintaining our dedication to excellence, with our sights set firmly on achieving full MDR certification in the near future!