PD Neurotechnology (PDN) has been certified by DQS Med with the CE Certificate Class IIa for its groundbreaking wearable medical device for continuous monitoring of patients with Parkinson's Disease, PDMonitor®.PDN has implemented and maintains a quality assurance system which applies to the final controls of the product. Through an audit, documented in a report, performed by DQS Medizinprodukte GmbH, it was verified that the company's quality assurance system fulfills the requirements of Annex VI of Council Directive 93/42/EEC concerning medical devices with respect to PDMonitor®.
Prof Dimitris Fotiadis, R&D Director and Co-Founder of PDN, commented: “We are very proud to receive the CE marking certificate for PDMonitor®. It is a great milestone achieved, validating once again our vision and the team’s and company’s capabilities and performance”.
You can find the press release here.