ISO 13485:2016 certification for design & development

P3Lab receives ISO 13485:2016 certification for design and development of eye tracking devices

In summary

P3Lab, a European startup founded in 2020 is developing NeuroClues®, a medical device based on eye tracking to support early diagnosis and prognosis of neurological diseases.

NeuroClues® brings the state-of-the-art eye tracking research to the consultation. Thanks to NeuroClues®, neurologists will instantly quantify their clinical examination while removing the need for complementary exams, thus decreasing by months the patient’s time to a diagnosis. This breakthrough innovation allows detecting 5 years in advance specific symptoms like gait freezing.

The company has just received the ISO 13485:2016 certification for design and development of eye tracking devices. P3Lab reaches a new milestone by becoming a certified medical device producer.

Louvain-la-Neuve, Belgium, 9 June 2022 – P3Lab announces it has just received the ISO 13485:2016 certification for design and development of eye tracking devices.

P3Lab is on a mission to propagate an eye-tracking solution (NeuroClues®) to help objectively diagnose neurological diseases such as Parkinson, Multiple sclerosis, Traumatic Brain Injury and Alzheimer which collectively affect 3% of European and North American populations.

This certification is a new milestone reached for P3Lab. It brings the company one step closer to its ambition of to become an industry leader targeting the greatest threats to public health.

On the back of a strongly positive feedback from early enthusiastic practitioners, P3Lab is now working towards its next milestone, the CE-marking of NeuroClues® as a class IIa medical device as per the Medical Device Regulation (EU) 2017/745.

The P3Lab team is proving they can reach their ambition to deliver an innovative medical device to better identify the greatest threats for our healthcare system.” says Olivier Legrain, Chairman of P3Lab’s board and CEO of IBA, world leading provider in protontherapy solutions.

Pierre de Waha, Sr Investment Manager at Invest.BW, one of P3Lab‘s main investors explains “P3Lab delivers according to their roadmap; they are confirming  their strong competitive edge. This strong achievement reinforces our long term commitment to support P3Lab in their development.”

The team is now finalizing the development of the product, and planning its first assessments. Having NeuroClues tested in a front running laboratory like Paris’ Brain Institute will ensure that it fulfills the highest performance requirements and satisfies its future users.

P3Lab is also preparing or expanding the scope of its ISO 13485 certification towards production, distribution and servicing activities.  We are well positioned to have our Quality Management System updated and ready for being audited in the coming months, by the time we apply for the CE-marking of NeuroClues“ explains Frédérique Boël, Head of Quality and Regulatory Affairs 

“This accomplishment proves P3Lab is now a medtech company in its own right. Now we are entitled to solve the practitioner’s pains and well underway to get the first NeuroClues tested by early enthusiasts. . This would not have been possible without the strong drive from the entire team and the support of our partners.” Antoine Pouppez, CEO of P3Lab.

neuroClues® is a registered brand of P3Lab, currently under research and development phase. It will be available for sale when regulatory clearance is received.

Are you enthusiastic about NeuroCluesTM and want to share it with your colleagues?

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