Instant compliance review of your MedTech
regulatory documents
The Audit Simulator
FAQ
Got Questions? We’ve Got Answers.
We are the experts in compliance and mock audits automation.
How does your AI solution help reduce the time it takes to certify medical devices?
Our platform automatically reviews and flags potential regulatory gaps before documentation is sent to Notified Bodies. By catching issues early, you cut down on costly back-and-forth revision cycles, which in turn accelerates the overall certification timeline.
My team already has a regulatory expert—why do we need your tool?
We don’t replace human expertise; we enhance it. Our AI system acts like an “extra pair of eyes,” screening thousands of requirements quickly and accurately so your team can focus on high-level decision-making rather than time-consuming manual checks.
Is the solution adaptable to different device risk classes and changing regulations?
Yes. Our platform is built to handle a wide range of device classes and is updated regularly to keep pace with evolving guidelines (e.g., EU MDR changes). This future-proof design ensures you stay compliant even as regulations shift.
How do you ensure data privacy for sensitive technical documentation?
We offer on-premise and secure cloud deployment options that adhere to strict data privacy standards (ISO 27000, HIPAA, etc.). This means your confidential documents stay under your control and remain safe from unauthorized access.
What kind of support do you offer for implementation and training?
We provide full onboarding support, including expert guidance on integrating our tool with your existing systems. Our team also conducts tailored training sessions to help your staff adopt the platform smoothly and get the most out of its features.
Can your AI handle partially complete or evolving documents during the development process?
Absolutely. Our platform supports iterative document reviews, so you can upload drafts at various stages. It flags gaps and non-conformities early on, helping you refine your submission before finalizing it for the official review process.
How do regulatory authorities view AI-generated assessments—do they accept these findings as reliable?
While the final decision always lies with the Notified Body or authority, our AI acts as an advanced screening tool that has garnered positive interest from regulators. It delivers consistent, transparent assessments that speed up review times, but the ultimate “stamp of approval” still comes from the official certification body.