View your testing strategy and regulatory plan all in one place.
Your affordable, intuitive solution for regulatory success.
Don't let regulatory compliance be a roadblock to your success. Let Tento+ be your partner in navigating the complex world of medical device regulation
See the big picture at-a-glance
Better work flow management
End-to-end visibility across the development journey improves workflow for you and the whole team. Easily track progress from source code to software unit, function, and product requirement.
Secure funding
Communicate development progress to all stakeholders. Ensure they are on-board, and investments are secured.
Headstart
Clear the regulatory cobwebs with our digital browser-based solution that acts a a central hub for all your regulatory needs
Plan
Designed with ease of use in mind, our platform is perfect for those without expert regulatory experience. Track your progress directly on the platform from start to finish.
Test
Create test records, results, and requirement traceability matrices all in one seamless platform, saving valuable time and minimizing errors
Collaborate
Use our Teams manager to allow your team to communicate directly and see the big picture at a glance, allowing for a more efficient regulatory process.
Evidence
Easily access and download compliant technical files directly from our platform, saving you time and effort. If you're stuck , access one of our available templates
Personalise
Only focus on the regulations that matter to you through our AI-driven personalised regulatory checklist, tailored to your specific device through inputs given by you
Start-up venture achieves Class I CE status just 6 months after prototype
The start-up venture partnered with us to achieve Class I CE Status and secure funding from investors for their breakthrough non-invasive microcirculation technology.
Meet major deadlines
Be first-to-market with Tento, set major design milestones, and keep on track of progress. Accelerate the self-certification process to achieve CE in time for a product launch.
Start-up venture achieves Class I CE status just 6 months after prototype
The start-up venture partnered with us to achieve Class I CE Status and secure funding from investors for their breakthrough non-invasive microcirculation technology.
Fuss-free documentation
Export test evidence and documentation from Tento when you need it. Test reports and evidence can be downloaded quickly ready for submission to notified bodies.
Documentation in one place
Store requirements traceability matrix, test protocols, and test evidence in one place. Easily locate information on Tento to demonstrate compliance to notified bodies.
Fuss-free documentation
Export test evidence and documentation from Tento when you need it. Test reports and evidence can be downloaded quickly ready for submission to notified bodies.
Documentation in one place
Store requirements traceability matrix, test protocols, and test evidence in one place. Easily locate information on Tento to demonstrate compliance to notified bodies.
Built by experts
Tento is built from 40+ years’ experience, spanning 350+ projects for 250+ customers worldwide. Companies from all industries trust in Tento.
Product verification accelerated by 3 months for multinational healthcare provider
This health solutions company was able to successfully test their blood cell counting device for patients with chemotherapy, in preparation for regulatory submission and clinical trials.
Product verification accelerated by 3 months for multinational healthcare provider
This health solutions company was able to successfully test their blood cell counting device for patients with chemotherapy, in preparation for regulatory submission and clinical trials.
Evidence preperation
Documentation management
Design assistance
Verification & validation
Strategy development
Self-certification support
MDD to MDR transition
Software engineering
