Charco Neurotech Achieves ISO 13485:2016 Certification
We are proud to announce that we have achieved ISO 13485 certification, the internationally recognised quality management system standard for Medical Devices, issued by Kiwa Ltd, a UKAS-accredited certification body. This marks a pivotal step in our mission to bring CUE1+ to people with Parkinson’s through healthcare systems worldwide.
What ISO 13485 means
ISO 13485 is the global benchmark for quality management in medical device organisations. Achieving it is not a simple administrative exercise; it requires every part of an organisation to demonstrate that its processes, systems, and controls consistently meet the rigorous standards expected of a regulated medical device company, from initial design through to post-market customer support.
Certification across both of our sites confirms that Charco Neurotech operates consistently and verifiably at the level expected of a truly global medical device company from the facility where CUE1+ is designed and manufactured, to the team dedicated to delivering it into the hands of those who need it most.
Our certified sites
Importantly, this certification spans our entire international operation; both of Charco’s sites have been assessed and certified under the same standard.
What this means for the people we serve
For a company built around improving the lives of people with Parkinson’s, this means more than a compliance milestone.
- It reinforces the care and precision that goes into every device we make.
- For healthcare systems and clinical partners, it’s the foundation for meaningful collaboration.
- And for global markets, it sends a clear signal: Charco Neurotech is primed for expansion.
CUE1+ is a non-invasive, drug-free wearable that uses vibrotactile stimulation to help people with Parkinson’s move more freely, reduce stiffness, and improve balance and stability. The evidence supports it. And now our quality framework verifiably matches our ambition.
“This certification confirms that Charco Neurotech operates at the standard required of a true global medical device company. It opens the door to healthcare system partnerships, clinical procurement pathways, and international market access, and ultimately means CUE1+ can reach more people with Parkinson’s, wherever they are in the world.”
Iain Strickland PhD, Chief Commercial Officer — Charco Neurotech
A step towards global healthcare access
ISO 13485 certification is a foundational requirement for engaging with regulated healthcare markets worldwide. As Charco Neurotech looks to expand access to CUE1+ through NHS procurement pathways, international regulatory frameworks, and clinical partnerships globally, this certification provides the verified quality foundation those conversations require.
CUE1+ deserves to be in the hands of every person with Parkinson’s who could benefit from it — wherever they are in the world. This milestone brings us meaningfully closer to making that a reality.
LFH Regulatory
A huge thank you to the team at LFH Regulatory, a specialist medical device regulatory consultancy, who have supported us every step of the way. Their expertise in QMS implementation made a genuinely complex journey manageable, and we couldn’t have got here without them.
Visit LFH Regulatory →
And to the entire Charco team, across Cambridge and South Korea — this achievement belongs to you.
The mission continues.
Move Freely. Live Fully.