Product Update: MHRA Class I Registration Confirmed For SpeechCursor and SpeechAmbient

We feel it important to confirm that SpeechCursor and SpeechAmbient are officially registered as Class I Medical Devices with the UK Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA Class I medical device registration affirms that our products meet the essential safety, quality, and performance standards required for use in UK clinical environments. This certification reflects our unwavering commitment to delivering high-quality, clinically safe, and reliable solutions.

This is compliant with the recent guidance from NHS England on the safe and secure adoption of AI scribe technologies – a conversation in which we are proud to already meet and exceed expectations.

Importantly, this is not a new step in our approach to security and governance. Security and governance are paramount, and our solutions are built from the ground up to align with the highest standards in healthcare security, including:

• MHRA Class 1 Medical Device

• DCB0129 Clinical Risk Management
• ISO 27001 / 27701 (information security management)
• Cyber Essentials Plus (a UK Government standard for technical controls to help organisations improve the level of IT infrastructure security)
• DSPT (Data Security Protection Toolkit, an NHS self-assessment all about handling sensitive info/data securely)
• DTAC (NHS ‘Digital Technology Assessment Criteria’)
• DPIA (Data Protection Impact Assessment)
• DPA (Data Processing Agreement)

Our in-house Data Protection Officers (DPOs) oversee every step of our development and deployment processes to ensure data privacy and compliance are always front and centre.

As an established provider with over 25 years of experience in healthcare technology, we are trusted by clinicians and healthcare organisations across the sector, globally. This recognition reinforces our reputation for delivering innovative solutions that meet the highest standards of compliance, usability, and patient safety – while continuing to support healthcare teams with tools that truly make a difference.

What this means:

• Regulatory assurance for UK healthcare providers
• Safe and compliant deployment across NHS and private settings
• Seamless integration into clinical workflows – supporting ambient speech capture, hands-free documentation, and structured note generation

SpeechAmbient
Transforms real patient-doctor conversations into accurate, structured clinical documentation – ambient speech AI that listens, understands, and reports for you.

SpeechCursor
Dictate. Anywhere. Instantly. Plug our SpeechCursor into any app. Just click and speak with highly specialised medical AI speech technology.

Thank you to all of our teams for helping us reach this important step. For more details or to request further information on any of our products contact: info@g2speech.com