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.”

Morgane le Guilcher,
Director of Quality – Safety – Environment

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 This directive has now been replaced by a mandatory European regulation effective as of May 26, 2021.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

Cybersecurity – HDS – ISO27001

Data protection and privacy, compliance with the GDPR… the healthcare sector is one of the most sensitive when it comes to these issues.

Healthcare Data hosting and 27001 certifications (for the suitable products), “security by design”, intrusion tests by independent auditors, Disaster Recovery Plan: to ensure the safety of patients and your establishments, data confidentiality and service continuity, Evolucare devotes constant efforts to protecting your solutions against malicious or accidental disasters.

The international ISO 27001 standard forms the basis of the french HDS (Health Data Hosting) certification reference framework.  

We set up automated vulnerability tests, using tools integrated into the IS, plus an intrusion test campaign on software, carried out in collaboration with a specialist ANSSI*-certified company. Together with our maintenance teams, we emphasise good practice and respect for the protection of personal data when working with customers.
*french IT security national agency

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.

Evolucare is certified ISO / IEC 27001:2017 compliant – Health Data Hosting (HDS) Outsourcer – LSTI Certificate N°11278-2 for the products and services concerned. The scope of the ISMS covers the development, provision and outsourcing of hosted applications.

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 ...

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