Keosys

"An European leader in medical imaging IT applied to clinical research and diagnosis, for medical imaging data management: diffusion, distant analysis, devices and software"

Created in 2001, Keosys is an independent company based in Saint Herblain (France), specialized in the design, development and commercialization of solutions to analyze and diffuse medical images. The solutions are ready fo

r most of the imaging modalities: radiology (CR, CT, MG, MRI and US), nuclear medicine (PET / CT, SPECT / CT, PET / MRI, NM) and can be adapted for others like (Doppler, ECG, EEG, EMG, Digital Slides…). Keosys draws on extensive technology and expertise from a Team of physicians and engineers specialized in telecommunication systems, medical imaging ergonomics and software. Keosys are involved in many collaborative projects, in close relation with Key Opinion Leaders in medical imaging, within research laboratories, government organizations, research centers and private companies. Those partnerships lead to the development of a range of premium and innovative solutions enabling Keosys to be granted by the French Ministry of Research through the CIR agreement. Those projects focus on the following areas:
• Web services for medical imaging data management
• Developments in medical imaging devices: diagnosis software and workstations
• Security of information systems and data transmission
The products developed by Keosys have the following main strengths:
• Simple functions for intuitive operation
• Optimized ergonomics for an improved workflow
• A reliable technique for time and diagnosis efficiency
• The high security exchange information: the data sent is encrypted, de-identified and securely stored

With an annual growth of about 30%, Keosys is now developing its global distribution network and offers technical support quickly and efficiently. EXPERTISE & INNOVATION
Keosys has become a major key player in nuclear medicine thanks to the design, ergonomics and reliability of its products. Experience gained through collaborative projects with institutions and close partnerships with research laboratories, Keosys has developed innovative solutions for today’s and tomorrow’s market whilst satisfying EU and FDA requirements. More than 200 customers mostly across Europe trust us and rely on Keosys 10 year’s expertise in medical imaging and network. Keosys is a key player and a partner of choice for medical imaging projects related to medical imaging data management. From project setup, implementation, training and maintenance our Customer Support department is here to ensure a personalized service. Keosys quality insurance system, based on ISO 9001 and ISO 13485 guide us to ensure continually customer satisfaction. Keosys is specialized in the design, development and commercialization of hardware and software solutions dedicated to medical imaging data display, multicentre broadcast, analyze and reading. For medical diagnosis aid, health professionals use those solutions. We have defined our vision for the future: be a recognized and uncontested actor in nuclear medicine and more generally in medical imaging in France and abroad. To do it, Keosys priorities are to:
• Satisfy its customers and their patients health by providing products and services of optimal quality, on time and to agreed costs.
• Respect and follow European and Canadian legislation developments, in particular the 93/42/EEC Directive requirements about medical devices (EEC) and Medical Devices Regulations (Canada)
• Satisfy our shareholders by generating a turnover and margin in line with objectives planned.
• Meet our staff in ensuring its safety, training needs and an increase in line with its expectations. To meet these requirements, since 2006 Keosys committed in the quality management way with the ISO 9001 :2000 Certification obtained in 2006 followed by the ISO 13485 :2003 appendix 2 certification in 2008 and finally the FDA certification in 2009. Keosys has established, maintained and continuously improved a quality management system based on process approach and risk management. Risk management takes a prominent place in Keosys and comes in several areas :
• Risk management projects,
• Risk management process,
• Professional risk management,
• Product risk management. All actions implemented within the company are focus on the same objective: after its success in France, Keosys is identified today as the European leading management platform for exchange and multicenter proofreading medical imaging files. Our ambition now is to extend this position to other continents through the establishment of strategic partnership with companies who share Keosys values and whom notoriety is already acquired in those countries. CUSTOMER REFERENCES
Keosys have more than 150 European and American reference centers with nuclear medicine and radiology experts.
• Hospitals,
• Cancer centers,
• Clinics,

Pharmaceutical Industry
• Pharmaceutical Companies
• Academic Research Centers
• CRO

In focus on the thematic of the SNM Clinical Trials Network project, the Keosys business can be illustrate by the following last significant projects with Academic research Groups or Pharmaceutical Companies. QUALITY MANAGEMENT AND RISK ASSESMENT PROCEDURES
The Keosys quality management system is certified ISO 9001:2000 (AFAQ) and ISO 13485:2003 (GMED) for the “Design, manufacturing and sales of software and hardware solutions for medical imaging applications. Servicing: installation, release, training and technical assistance”. Keosys fulfill the quality systems requirements for the following regulatory areas:

European Economic Community. All Keosys products are CE marked (Approval of full quality assurance system, annex II section 3 directive 93/42/EEC concerning medical devices). Canada. The Keosys quality system is certified according to the rules of the CMDCAS program requirements / CMDCAS SQ. Part of Keosys products are FDA compliant, concerned by a 510(k) and meet the regulatory requirements of the 21 CFR part 115
Keosys provides a risk assurance policy for each study for an amount of 1 M€. FDA
Keosys Imagys Web solution has reveived in October 2010, 510(k) Clearance from the U.S. Food and Drug Administration (FDA) for its Web-based Medical Imaging Data Management for clinical trials. The FDA approval ensures secures medical imaging data: upload, transfer, management, viewing, reviewing, printing, storage and archiving. Imagys can thus support the management of the imaging parts of a clinical trial workflow including the following steps:Quality, Control, data processing and audit trail.