19/09/2023
We are thrilled to announce that CSDmed is now part of the prestigious AFNOR Adherents Club, a significant milestone that underscores our commitment to excel in quality and innovation.
AFNOR presentation
With 1,480 members of AFNOR Association, a workforce of 1,170, 39 offices in the world et 69,000 customers, the AFNOR Group designs and deploys solutions based on voluntary standards around the world. The Group serves the general interest in its standardization activities and provides services in such competitive sectors as training, professional and technical information and intelligence, assessment and certification.
AFNOR is vested with a general-interest mission, as defined by the French Standardization Decree of 16 June 2009, to coordinate leadership of the French standardization system.
Presentation of CSDmed
CSDmed is the first Monegasque consulting company in the development of medical devices (MD). We have been established in the principality of Monaco since 2020, do not hesitate to come and visit us, we will be happy to welcome you.
Our team of consultants assists our clients in addressing technical challenges during development, quality assurance and regulatory compliance challenges.
You are looking for an expert to manage an R&D subject (design, creation of a DHF, management of verification and validation activities, documentary writing), you are looking for an independent QA to build your Quality Management System (QMS), for manage your CAPA and non-conformities, to improve your processes or your templates, you are looking for a professional to advise you and help you determine your regulatory strategy through RDM 2017/745, through FDA requirements or through of the MDSAP (Medical Device Single Audit Program in Canada), CSDmed has the solution.
The benefit of this membership for CSDmed
This membership will afford CSDmed a multitude of benefits:
Gaining efficiency: By joining a robust network of experts, we can boost our efficiency and deliver high-quality services to our clients.
Influencing standards: We will now have a voice to influence standardization strategies and actively participate in the drafting and updating of norms. CSDmed thus becomes a member of the AFNOR/S95B medical device standardization commission: quality management and corresponding general aspects of medical devices, which is the mirror structure of the famous ISO TC210.
Staying at the forefront: With monitoring and participation in new norms, we will always be at the cutting edge of our field.
Strengthening our standardization skills: This membership offers training opportunities to continue to strengthen our expertise in standardization.
This is an exciting step for us, and we are eager to share the benefits of this membership with our clients.
Our expertise
CSDmed brings its expertise and a methodical approach to its customers, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts, who will be able to handle the challenges your are facing.
To learn more about what our new status means for you and to find out how we can further serve your needs, Contact Us Today!
