Quality - Safety - CertificationsISO 9001 - ISO 13485 - CE
An overall desire for continuous improvement
In 2014, Evolucare implemented a Quality Management System compliant with ISO 9001 and ISO 13485 standards. The purpose of this initiative is to define an internal organization for the company in order to streamline operations, continuously improve client satisfaction and meet regulatory requirements such as CE marking. These different reference systems are constantly changing.
Consequently, this continuous improvement approach is now being supplemented by action plans aimed at compliance with the new European regulation for medical devices.
“The Quality team works with all the department managers on all the group’s processes, from sales to customer service, including purchasing and production.”
Marion Dansette, Coraline Halouani-Pasquier, Quality and Regulatory Affairs Managers
New European regulation
The new European regulation, called MDR 745/2017, is a major change.
Indeed, CE marking was based on the European directive 93/42/EEC, applicable since 1993 and transposed into the legislation of each European country. This directive has now been replaced by a mandatory European regulation effective as of May 26, 2021. It is stricter and more comprehensive than the directive.
Our Quality team is working to adapt our QMS accordingly, to prepare the marking of our products based on this new regulation and to guarantee our clients the safety of our products by reinforcing the post-marketing supervision of software dedicated to the monitoring of clinical performance, as required by the MDR.
“Our risk management method has been enhanced as a result of the new regulation, which places special emphasis on benefit/risk analysis.”
Sébastien Decaix, Quality Production Project Manager
Our quality policy
- The continuous improvement of the Group’s operational performance
- The continuous improvement of our customers’ satisfaction
- The consolidation of communication and cohesion among the Group’s teams
- The desire to expand internationally
- The development of skills through the continuous training of our employees
- The continuous evolution of the methodologies and tools used
- The reinforcement of rigour in the deployment and maintenance of our solutions
- The consideration for quality of life at work and safety
- The understanding of and compliance with our processes by our employees, sub-contractors and partners
- The development of innovative products
Labels & certifications
Evolucare Technologies is ISO 9001: 2015 and ISO 13485: 2016 certified, and meets the regulatory requirements for CE marking of medical devices:
- Osiris, our Patient Record, is a Class I medical device,
- Our critical care software, Evolucare Anesthesia and Evolucare Intensive, are Class IIa,
- Evolucare Imaging, our RIS-PACS solution, is Class I,
- Evolucare Uview/OphtAI is a Class IIa medical device,
- Our viewing consoles, Evolucare View and ECS View Web, are Class IIa,
- Smart Angel, our software dedicated to post-operative monitoring of vital physiological parameters, is a Class IIa medical device.
All the news of the Quality activity
The ISTQB is the International Software Testing Qualifications Board. This organization offers a certification that is recognized worldwide. Achievement of a new ISTQB certification for two of our testers Two members of the team obtained their ...
A crucial step for the regulatory requirement coming into force on 1 January 2021 We are pleased to inform you that our Administrative Patient Management (APM) software solution, Medsphère, has obtained INS accreditation following the CNDA review conducted on ...
#OphtAI, the new #AI product line of #Evolucare and #ADCIS, gets CE Medical Device Certification. Our Artificial Intelligence, now available for clinical use, identifies diabetic retinopathy from a mere retina fundus image with performances on par with the best ...