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.

Finlay, Founder at VEIN IR

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. 

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.

Alison Sundset, CEO Holocare

I like to think of Tento+ as an engineer’s new best friend in tackling medical device regulation.

Dr Nicola Thorn, CEO of AND Technology Research

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:

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:

Our Features


Design Controls

Create device specification, test plans and perform testing runs, all whilst maintain full traceability.

Risk Managment

Undertake risk analysis, define risk controls and verify risk measures easily in one place.


Share devices with team members, and assign tasks to others or yourself to keep on top of your progress.

AI Assistant

Each module comes fully equipped with GeMA, your Generative MedTech Assist to help you get compliant quickly.

How it works

Create an account & start your journey

Begin your compliance journey by creating an account. It's as simple as providing your email address. Once you're in, you'll be able to create your first device.

Explore the free Tento+ demo service

Take the tour of our tool for free with our example medical device and witness the system's functionality firsthand.

Get started on your own device

Ready to make your own device? Dive in and embark on your compliance journey with confidence. Provide a brief device description, use the standards' planner, and utilise GeMA to become compliant.

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.


1Is there a minimum number of licenses I need?
Nope, you can start with just 1 and then scale more licences as and when you need them.
2Are there any fixed term contracts?
Only if you want there to be. Our standard licences are on a monthly rolling basis., but you can get a better rate if you commit for longer as part of our enterprise package.
3Can I really get compliant in weeks?
Yes, and we have done it ourselves. Tento+ comes equipped with features to help you get compliant in weeks, from generating requirement specifications, to handling your risk management and analysis. But in case you don't know where to begin, our "compliant in 4 weeks" programmes are there to guide you through the process as well.

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.