DiCro: Digital Compliance
Ensuring Clinical Safety and Regulatory Compliance
With decades of expertise in managing clinical operations and clinical risk, DiCro specializes in providing comprehensive Digital Compliance Services, helping health IT suppliers and healthcare organizations meet mandatory UK standards, such as DCB0129 and DCB0160.
We specialize in developing high-quality DCB documentation, such as conformance assessments, CRM plans, and Clinical Safety Case Reports, all designed to create a compliant and well-maintained CRM file.
OUR SERVICES
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Clinical Safety Officer (CSO) Provision
We offer highly qualified Clinical Safety Officers to guide your organisation through compliance requirements, ensuring your projects address all relevant clinical safety risks.
DCB 0129 Compliance Support
Compliance with DCB 0129 is essential for suppliers of health IT systems. Our team develops Hazard Logs and Safety Cases using our tried and tested templates, making the process less resource-intensive for you.
DCB 0160 Compliance Support
For healthcare organizations, we provide comprehensive support to complete DCB 0160 activities, ensuring that your health IT systems are safely implemented and compliant with all regulations.
Medical Device Compliance
We help navigate the regulations and facilitate discussions with regulators to achieve regulatory compliance.
Our Approach
We have designed an intuitive model to guide you through interpreting DCB standards from the initial concept stage to post-deployment monitoring. Starting your clinical risk assessment early is essential to ensure that your product design decisions are cognizant of the key risks.
Hazard Assessment
A comprehensive and routinely updated Hazard Log is a cornerstone of effective clinical risk management. Our approach incorporates Hazard Workshops as a platform for brainstorming relevant risk areas, along with suitable control measures. These workshops are facilitated by experienced Clinical Safety Officers who guide the discussion to unearth the most pertinent areas which could lead to clinical safety hazards and adverse health outcomes for patients. Conducting a Hazard Workshop at the early stage of product design and development can help avoid future costly changes.
WHY CHOOSE DICRO?
WHY CHOOSE DICRO?
PROVEN EXPERTISE
Drawing on decades of clinical operations and clinical risk management experience, our team helps to highlight all relevant risks which could create safety hazards for patients.
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TAILORED SOLUTIONS
We customize our services to meet your specific needs, ensuring that you receive the most relevant and effective support.
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EXPERT PROCESSES
Using our established methods, Hazard Workshops, and tried and tested templates, we facilitate expert assessments ensuring DCB compliance.
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CONTINUOUS SUPPORT
From initial assessment to ongoing compliance management, we are with you every step of the way, ensuring your projects are always on the right track.
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CONTACT​
At DiCRO, we’re here to answer your questions, provide information, and discuss how we can collaborate to drive innovation in healthcare. We welcome your enquiries and look forward to connecting with you.
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Explore possibilities and drive healthcare innovation. Call 07443940319 or email liba@dicro.co.uk.
GET IN TOUCH
Ready to develop your clinical safety and compliance processes? Contact DiCro today to learn how we can support your organisation’s clinical safety strategy and regulatory compliance.
For more information about our digital health compliance services, call us 07443940319 or email us at liba@dicro.co.uk.