Quality - Safety - Certifications

ISO 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

 

Evolucare Quality Management System

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 This directive has now been replaced by a mandatory European regulation effective as of May 26, 2021.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

  • Increasing the ongoing satisfaction of our customers
  • Skills and continuous training of our employees
  • Continuous improvement of the methodologies and tools used
  • Rigor in the deployment and maintenance of our solutions
  • Taking into account quality of life at work and safety
  • Discussion and team cohesion
  • Knowledge and respect of processes by our employees, subcontractors and partners
  • Desire to expand internationally with 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

New ISTQB certifications achieved by our test team

New ISTQB certifications achieved by our test team

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 ...

Medsphère obtains accreditation for INS management

Medsphère obtains accreditation for INS management

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 gets CE Medical Device Certification

#OphtAI gets CE Medical Device Certification

#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 ...