THE HAGUE, THE NETHERLANDS – November 15, 2021 – Today, Corsano Health, a leading MedTech company developing, producing, and marketing medical grade continuous health monitoring announced its certification complying with Annex IX (MDR) and EN-ISO 13485 standards.
ISO 13485:2016 represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices, thus ensuring product safety and effectiveness. The Notifying Body performed an audit of the quality management system of Corsano Healthcare B.V. in conformity with Annex IX (MDR). The audit scope and objectives were agreed upon.
Design & Development, Production, Distribution, Storage and Service of software applications and associated hardware to provide automated regular measurements of activity and vital signs in the area of health monitoring.
Software applications and associated hardware that utilise a photoplethysmogram to provide automated regular measurements of activity and vital signs in the area of health monitoring.(Class IIa; Z12040113 Regional Plethysmographs; MDA0203)
Corsano Healthcare B.V. presented information on changes in the organisation, the devices, the quality management system, and any other related regulatory issues. The lead auditor concludes that:
1. The quality management system and sampled technical documentation conforms to the requirements of the audit criteria, namely Annex IX (MDR) and EN-ISO 13485 and that the defined processes and documentation of the management system developed by the customer are effectively implemented.
2. The quality management system is capable to meet the applicable requirements and expected outcomes.
3. The quality management system is effective in ensuring that the quality objectives of the manufacturer are met.
4. The quality management system is documented in a systematic and orderly manner in the quality policy, quality manual, quality plans and records.
5. The (top) management is actively involved in the use and implementation of the quality management system and does reflect this on the company.
6. Continuous improvement is secured within the processes as described in the quality management system.
About Corsano Health
Corsano Health, based in The Netherlands with offices in Switzerland, is a leading wearable MedTech company developing, producing and marketing medical smart monitoring devices designed to measure vital parameters 24/7 using wireless, non-invasive, and medical-grade technology. The Corsano brand name is derived from in corpore sano (in a healthy body). Corsano’s CardioWatch 287 is a cardiac arrhythmia screening system that provides a simple and effective method for continuous monitoring of up to 19 vital parameter measurements (i.e., Heart Rate, RR Intervals, Respiration Rate, SpO2, Sleep, Activity, ECG, BIOZ, Core Body Temperature, Cuffless Blood Pressure). More information at http://www.corsano.com
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