The tool that generates a compliant design history file in weeks.
Tento+ helps you manage design and risk compliance of medical devices across all major regulation (US, UK, EU).
Tento+ captures requirements, design traceability, risk controls, and verification evidence, streamlining the process and saving hundreds of hours. It offers in-built guidance, audit-ready document generation, and our personalized generative MedTech AI assistant, GeMA, so you can get compliant quicker.
Tento+ is more than just a piece of software; it’s transforming how teams achieve and maintain compliance.
Using Tento+, we became compliant to IEC:62304 in just four weeks. We now have audit-ready documentation, and a process we know we can manage long into the future.
Spending endless hours researching?
Quoted tens of thousands for support?
You aren’t alone; over 60% of MedTech execs say regulation is their biggest challenge. But it doesn't have to be.
Tento+ is the tool you need to get compliant and maintain it.
How?
Well, it is smart… really smart. Included in all our modules is GeMA - your own, personalised, generative AI assistant to guide you. Add that to the access to resources, expert advice, and templates galore, and you'll be compliant in no time.
Tento has been a real game-changer for us. It makes the whole regulatory process so much more manageable and efficient.
I like to think of Tento+ as an engineer’s new best friend in tackling medical device regulation.
Say goodbye to tedious paper-based methods and embrace a different approach where requirements auto generate, traceability is simple, and configuration doesn't cause you a documentation nightmare.
Just some of our happy customers:
ABOUT TENTO+
Built from experience, designed for ease.
Our founders have combined over 60 years worth of compliance knowledge into one simple to use software tool. It is designed for SMEs looking for a simple way to maintain compliance and doesn't require a huge regulatory team to manage.
We think it's so simple in fact, you won't need a walkthrough or demo session. You can just start ... straight away ... today ... it's that simple.
As Featured in:
WHY CHOOSE US
Our Features
Design Controls
Risk Managment
Teams
AI Assistant
Expert Support
TENTO+ SOLUTION
How it works
Looking for hands-on support?
Our GET COMPLIANT IN 4 WEEKS programmes offer the hands-on expert support that is hugely effectively in getting compliant quickly.
Over the 4-week programme, you'll get a dedicated regulatory expert, a deep dive into your product, all the templates you need, a bespoke action plan and compliance report, plus we'll give you Tento+, completely free for that month.
Our flexible pricing is 90% more cost effective than other providers.
No long term contracts. No minimum subscriptions. Only pay for the licences you use.
One Module
£99.00
Get started with one Tento+ module.
Choose from:
- Design Control or
- Risk Management
per month
Start with the area most relevant to you. All modules can work independently, and can be latter integrated into each-other as you progress on your journey.
- Design standards planner or safety checklists
- Document Checklist
- Requirements or Risk Control Manager
- Traceability tool
- Risk analysis or test management suite
- Issue tracker or risk configuration
- Full documentation export
Combined
£189.00
Combine modules and get a 10% discount.
Included both:
- Design Control and
- Risk Management
per month
Get complete control of your design and risk managment files. Both modules seamlessly allow you to integrate risk controls into design requirements.
- Get all features included with both modules
- Seamless integration between modules
- Select design requirement as risk controls
- Trace through risk control to verification and testing
- Hold risk reviews and design reviews in one place.
- How-to-guide so you can get started quickly
Enterprise
Let's chat
Enterprise plans includes access to experts, multi license teams and long term discounts.
Empower your entire team with our organisational plan, enabling seamless collaboration, unlimited users, and access to new features instantly.
- Access to personal regulatory expert to help define your product needs
- External product testing and QA
- Unlimited users, unlimited devices
- Early access to new features
FAQ's
Want to talk to one of our experts?
Tento+ is so simple, we don't think you'll need a demo session. You can just jump right in. But, if you'd rather chat it through with one of our experts, then book your free no-obligation demo now. We will walk you through the tool, the main factures, and explore how it can help you get compliant in weeks.