Frequently asked questions

Frequently asked questions

Straight answers about the 4-week free trial, security, and how Obodux works alongside your QMS.

The free trial

How does the 4-week free trial work?

Request a trial on our free-trial form. We review each request to check Obodux is a good fit: we work with medical device manufacturers preparing CE and/or UKCA technical documentation. Once you are approved, we email your access details. Trials are not instant self-serve, because reviewing requests lets us set up your workspace properly and arrange specialist support where it helps.

Is the trial really free?

Yes. The 4-week trial has no subscription charge, and we will never charge you for a plan you have not agreed. If you want to continue afterwards, we agree a plan with you separately. For pricing and package options, email hello@obodux.com.

How long does approval take?

We aim to confirm trial access within 48 business hours of receiving a complete request. If we need more information about your role or your devices, we will email you first.

Who is the trial for?

Obodux is built for small and medium-sized medical device manufacturers in the UK and EU, and for the RA/QA leads and founders working on their CE and UKCA technical documentation. It is not designed to replace a full eQMS, it cannot guarantee certification, and it is not available for consultancies to resell as a white-label service. FDA-only programmes are not our current focus.

What happens after the four weeks?

You choose. You can continue on a paid subscription, export your work in line with the product features and our End User Licence Agreement, or simply stop. We will never move you onto a paid plan automatically.

Using Obodux

Does Obodux replace our ISO 13485 QMS?

No. Obodux sits alongside your quality management system. It helps you write and structure your CE and UKCA technical documentation, with AI assistance and specialist review. Your QMS procedures and document control stay as they are, and many teams continue to use an eQMS or a controlled SharePoint process alongside Obodux.

Can we bring in our existing Word and SharePoint documents?

Yes. Most trials start with existing evidence, however scattered it is. We can import and structure your current files, and carry out a gap analysis on a section of your technical file (redacted if you prefer). The quality of the result still depends on your evidence and your team’s review: AI suggestions support your work, they do not replace regulatory judgement.

Will Obodux guarantee CE or UKCA approval?

No. Obodux is a documentation tool with optional specialist review. It does not provide legal or regulatory advice and cannot guarantee CE, UKCA, FDA or any other approval. Your organisation remains responsible for its technical documentation and submissions.

Security and data

How do you keep our technical documentation secure?

Obodux is a secure workspace for compliance documentation, with encrypted storage, role-based access controls and activity logging for a full audit trail. If your IT team needs more detail for due diligence, email hello@obodux.com.

Are you Cyber Essentials certified?

Yes, Obodux is Cyber Essentials certified. If your supplier assessment needs the certificate details, email hello@obodux.com.

Who can access our data during the trial?

Only the users you invite, with the roles you give them, plus the Obodux team members who need access to run the service or to carry out specialist review you have agreed to. If your IT questionnaire needs detail on roles or subprocessors, email hello@obodux.com.

Where do we send security or privacy questionnaires?

Email hello@obodux.com with “Security questionnaire” or “Privacy” in the subject line and we will come back to you.

Still have a question?Email hello@obodux.com and our team will get back to you, or request a free gap analysis.

Ready to structure your technical documentation?

Ready to structure your technical documentation?

Obodux is a SaaS platform that streamlines medical device compliance. Using AI tools and a secure workspace, it helps prepare CE, UKCA, and global documentation faster, stay audit-ready, and launch products confidently.

Compliance Disclaimer: Obodux provides tools to assist with regulatory compliance but does not guarantee regulatory approval. Users remain responsible for ensuring their compliance with applicable regulations.

Cyber Essentials   Certified

© 2026 Obodux. All rights reserved. Obodux is the MedTech compliance product from BORIS Software Ltd.

Obodux is a SaaS platform that streamlines medical device compliance. Using AI tools and a secure workspace, it helps prepare CE, UKCA, and global documentation faster, stay audit-ready, and launch products confidently.

Compliance Disclaimer: Obodux provides tools to assist with regulatory compliance but does not guarantee regulatory approval. Users remain responsible for ensuring their compliance with applicable regulations.

Cyber Essentials   Certified

© 2026 Obodux. All rights reserved. Obodux is the MedTech compliance product from BORIS Software Ltd.

Obodux is a SaaS platform that streamlines medical device compliance. Using AI tools and a secure workspace, it helps prepare CE, UKCA, and global documentation faster, stay audit-ready, and launch products confidently.

Compliance Disclaimer: Obodux provides tools to assist with regulatory compliance but does not guarantee regulatory approval. Users remain responsible for ensuring their compliance with applicable regulations.

Cyber Essentials   Certified

© 2026 Obodux. All rights reserved. Obodux is the MedTech compliance product from BORIS Software Ltd.