Resources for all.

Check out our resources for making compliance and regulatory easy. We hope they provide some useful insights and help demystify the steps required to get your products to market.

All resources can be viewed in your browser and are available for download as a pdf.

If you have any specific questions, please do not hesitate to contact us.

UK MDR Pathway

An example pathway on a page summarising all the key activities to access the UK NHS market access for medical device manufacturers.

How to align your AI governance with ISO42001

Our guide to using the ISO 42001 international standard to evidence good governance of AI.

Unsure about digital clinical risk management

A short briefing paper on digital clinical risks, AI concepts and new hazards associated with the use of AI to factor into clinical risk assessment.

Unsure about medical device labelling

10 design considerations for your medical device labelling.

Unsure about rules for using the UKCA marking

A summary of do’s and don’ts when using UKCA marking.

Unsure how to register with the MHRA DORS

Follow this guide to get access to the MHRA device online registration service.

Unsure how to register a device with the MHRA

Our step-by-step guide to actually registering your device with the MHRA.

Unsure what to include in a 1 page regulatory strategy

Must-have content for your compliance and regulation strategy.

What to include in a SaMD technical file

Our guide to 7 key areas for your sofware as a medical device technical file.