The digital solution for your
Medical Device CE marking
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Discover how our solution simplifies the creation and management of your technical documentation in compliance with Regulation (EU) 2017/745
Cost Reduction
Cut your regulatory consulting costs by three: pay for expertise, not for administrative tasks.
Automated Templates
Easily generate your technical documentation, even for complex areas such as biocompatibility, electrical safety, or EMC.
Controlled Consistency
Eliminate redundant entries and reduce error risks with our semi-automated validation for always consistent files.
Compliance from the Start
Achieve compliance from the very first submission to the notified body and maintain it throughout your product lifecycle.
Centralized Management
Manage your entire product portfolio from a single, intuitive interface.
Simplified Regulatory Monitoring
Receive notifications with every regulatory update to stay continuously compliant.
Human support
Training, consulting, audits: our expertise by your side
Targeted, Qualiopi-certified training
To build skills and achieve your goals.
Personalized consulting
Benefit from personalized support tailored to your needs and resources.
Preparatory audits
Identify regulatory gaps and secure your CE marking submissions.
Ready to simplify compliance?
Request a free demo today and see how our solution can transform your regulatory workflow.
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