Digital Clinical Coding and Regulatory Services.
Get accessible support with your Digital Health Technology and Regulatory approvals.
Our services
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Clinical AI Coding
Providing highly skilled clinicians to accurately code your data, ensuring precision, compliance, and efficiency.
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NHS DTAC, DCB0129/ DCB0160
NHS regulatory compliance for the manufacturing and/or application in the deployment and use of Health IT Systems
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Software/AI as a Medical Device
Regulatory support with ISO and IEC standards and development of technical files
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Clinical Safety and AI Consultancy
System design, product and functionality support to ensure development of a clinically compliant and safe technology
90-Minute Review of Clinical Safety and DTAC Requirements/Documentation
Develop, review and evaluate your current Clinical Safety and Digital Technology Assessment Criteria (DTAC) requirements.
4 × 90 minute sessions developing/reviewing Clinical Safety, DTAC and Medical Device Documentation
Get your Health Tech company on the road to compliance!
Bespoke
Enquire within
Get from Zero to Compliant on your timeline.
Bespoke consultation to support your compliance needs.
Why us?
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Bespoke Advice
Advice personalised to your technology/device.
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Transparency
No hidden fees or timelines.
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Focus
Focussed reviews of your product(s) to recognise errors and implement solutions.
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Investment
Protecting your investment by providing key frameworks and strategies for success.
Testimonials
About
In an era of rapid technological advancement, the integration of digital solutions into healthcare has revolutionised the way we diagnose, treat, and manage patient care. However, with this progress it is imperative to ensure that these innovations are safe, reliable, and compliant with stringent clinical standards.
Compliance
Depending on your type of product compliance with one or both DCB0129 and DCB0160 is mandatory under the Health and Social care Act 2012. We help with DCB0129 and DCB0160 which are two standards provided by NHS England to ensure Health IT systems are safe to use in a live environment. In addition to supporting with GDPR compliance and NHS DTAC.
Clinical Safety
Digital Clinical safety emerges as a vital pillar in this transformative landscape. As an expert in this field, my team and I serve as the compliance support, providing the knowledge, guidance, and strategies necessary to navigate the complex and ever-evolving intersection of healthcare and technology.
Conformity
We provide support on Software and AI as a Medical Device regulation (SaMD, AIaMD). We provide an end to end service supporting with technical file development through to engaging with a Notified Body. We provide assistance with accreditations of relevant ISO (ISO 13485, ISO 27001, ISO 14971 etc) and IEC standards, deployments of Quality Management Systems (QMS), CE / UKCA certification for AI and software devices.
Confidentiality
Allow us to join in your journey that places patient well-being at the forefront, demonstrating that in the world of healthcare technology, a commitment to safety is non-negotiable. Together, we can pave the way for a healthier, safer, and more innovative future in healthcare.
Providing a safe space to discuss regulation and compliance.
In person and remote meeting options are available.
All discussions are confidential, with an open arena to ask any questions be provided with support.
