Certifications
Rigour at the foundation of our activity
Our business is to help companies and individuals better prevent health and safety risks. It seemed logical to apply this same requirement to our own operations: Medisur bases its growth on a socially responsible approach, encompassing social, environmental, and ethical aspects.
Dual expertise, two compliance requirements
At Medisur, trust isn't decreed; it's built on verifiable certifications and controlled processes. Our business is based on two distinct activities—laboratory supplying screening devices and training center—each subject to its own regulatory requirements.
Our laboratory
Our laboratory activity is based on ISO 13485 certification, guaranteeing the reliability of our screening devices and the rigor of our quality approach as a test designer. Since 2016, this work has allowed us to solidify our status as a leading French laboratory.
Our drug and alcohol tests are designed for single use and comply with the case law requirements of the Council of State (decree of December 16, 2016), with a reverse display guaranteeing the confidentiality of the results when read by the operator, and negative results in less than 2 minutes.
What this guarantees our customers:
We design and control our devices entirely, without relying on a third-party supplier for hardware reliability.
Ongoing compliance with the legal framework applicable to workplace screening
Traceability of batches as well as individual units thanks to a unique identification number, useful in case of inspection or dispute for our professional clients
Our training center
Medisur Formation, established in 2017, is Qualiopi certified. This certification, obtained and renewed through an independent audit, attests to our ability to design and deliver structured training courses eligible for professional training funding schemes.
What this guarantees to our business clients:
- Eligibility of our training courses for funding and support schemes
- Educational processes audited according to recognized quality criteria
- An official skills certificate is issued upon completion of each training course.
A COFRAC-accredited counter-expertise partner
Continuous regulatory monitoring
In the event of a dispute regarding a positive result, we provide a complete counter-expertise kit (sample collection swab, sealed security envelope, pre-identified transport envelope), which is sent to our partner laboratory in Limoges, accredited by COFRAC. Only this official report has legal standing to confirm or refute a positive result.
The framework applicable to workplace screening and professional training is constantly evolving. Our teams actively monitor these developments—case law from the Council of State and administrative courts of appeal, and upcoming legislative changes (particularly Article L. 3318-1)—to ensure that our certifications and practices remain aligned with the current regulations. When necessary, our partner law firm intervenes to validate any complex legal issues.
Questions about our certifications?
Our certifications and attestations are available on request for our professional clients, particularly in the context of your own compliance procedures or tender processes.
Want to join us ?
Frequently Asked Questions
Several objective criteria position Medisur among the leading players in occupational health and safety prevention in France: more than ten years of experience, dual certification...
Medisur's Qualiopi certification, obtained in 2023, covers all training activities. Depending on the modules, participants receive a certificate of participation (Road Risk...
Beyond its regulatory certifications, Medisur has been supported by the Bpifrance accelerator during its growth and holds the French Care label, which distinguishes French players in...
ISO 13485:2016 certification covers the import and distribution of medical devices and in vitro diagnostic medical devices, guaranteeing the conformity of the self-tests offered.