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Resources for all.

Check out our resources for making compliance and regulatory easier. 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.

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Mock audit questions to prepare for ISO27001

Our audit readiness briefing for Development Leads

What to include in a SaMD technical file

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

Unsure what to include in a 1 page regulatory strategy

Must-have content for your compliance and regulation strategy.

Unsure how to register a device with the MHRA?

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

Unsure how to register with the MHRA DORS?

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

Unsure about rules for using the UKCA marking?

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

Unsure about medical device labelling?

10 design considerations for your medical device labelling.

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.

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.