Safespaces Retains ISO 13485:2016 Certification

We’re pleased to share that we have successfully passed our annual ISO 13485:2016 audit, reaffirming our commitment to quality, safety and continuous improvement.

Earlier this week, we underwent our annual audit against the requirements of ISO 13485:2016 and successfully passed.

We first achieved ISO 13485 certification in 2025 and since then we have continued to maintain the systems, processes and quality standards required by this internationally recognised standard for medical device manufacturing.

For us, the annual audit is about more than simply maintaining our certification. It gives us an opportunity to review our processes, demonstrate our continued compliance and make sure that quality remains embedded across everything we do.

What is ISO 13485?

ISO 13485:2016 is an internationally recognised quality management standard specifically designed for organisations involved in the design, manufacture and supply of medical devices.

The standard sets out rigorous requirements for quality management systems, helping organisations consistently meet regulatory requirements and deliver safe, reliable and high-quality medical devices.

As a manufacturer of specialist medical devices, maintaining these standards is an important part of our commitment to the people who use our products, as well as the Occupational Therapists, healthcare professionals and organisations who specify them.

Our continued commitment to quality

Quality and safety have always been central to the way we work at Safespaces. Maintaining ISO 13485 certification gives us an independent framework for ensuring our processes continue to meet the required standards, while supporting our focus on continual improvement.

It also reflects the care and attention that goes into our products beyond the finished product itself from manufacturing and quality control through to documentation, processes and regulatory compliance.

“Successfully passing our annual ISO 13485 audit is an important achievement for Safespaces and reflects the commitment of our team to maintaining high standards of quality, compliance and continuous improvement. I would like to thank everyone who contributes to this work, with particular recognition for Amy and Jane, who have led the project and played a key role in maintaining our certification.” Alastair Demick, Managing Director.**