Embedded Files
For digital health companies and health IT suppliers, from concept stage to healthcare deployment. Our team understands how the clinical safety, data protection, regulatory and clinical evidence requirements fit together.
WHO WE WORK WITH
Companies building digital products for patients and clinicians
Companies building digital products for patients and clinicians
Digital health companies
Digital health companies
Patient apps, AI-supported tools and digital therapeutics, from concept stage onwards.
Health IT suppliers
Health IT suppliers
Systems used by NHS clinicians, such as prescribing, medicines information and multidisciplinary team platforms.
We work alongside your team from early design, so clinical safety, information governance and regulatory requirements are built into the product as it develops. This work provides assurance that your product is safe, compliant and ready for use in healthcare settings.
SERVICES
Four areas of support
Four areas of support
Each area can be commissioned on its own. Planning them together from the start avoids duplicated work and gives one consistent picture of the product.
Clinical safety
Clinical safety
DCB0129 Conformity Assessment
Clinical Risk Management Plan and File
Hazard workshops and Hazard Log
Clinical Safety Case Report
DCB0160 support for healthcare deployments
Medical device regulation
Medical device regulation
Medical device qualification and classification under UK MDR
Regulatory strategy and route to market
Class I, IIa and IIb technical documentation, MHRA registration and UK Approved Body submissions
Information governance
Information governance
Data Protection Impact Assessments (DPIAs)
NHS Data Security and Protection Toolkit
Privacy notices, data flows and processing agreements
DTAC evidence
Clinical trials, clinical evidence and funding
Clinical trials, clinical evidence and funding
Clinical trial and service evaluation design
Ethics and HRA approvals
NIHR and Innovate UK grant funding applications
APPROACH
From concept to deployment
From concept to deployment
EXAMPLES
Products we have supported
Products we have supported
Maternal health app
Maternal health app
An early-stage company launching a pregnancy and postnatal support app as a regulated medical device. We provided device classification, a hazard workshop and Hazard Log, the Clinical Safety Case Report, the DPIA and privacy notice, and grant applications.
Medicines information system
Medicines information system
A system used by NHS medicines information pharmacists. We provide DCB0129 clinical risk management and DCB0160 support.
Prescription ordering app
Prescription ordering app
A patient app integrated with NHS GP clinical systems. We provided DCB0129 clinical risk management and preparation for IM1 integration.
Leadership
Leadership
Liba Stones, Founder and CEO
Liba Stones has 20 years of clinical research experience. She was Head of R&D at the Royal Free, King’s College, Cumbria Partnership, and Barnet and Chase Farm, and Clinical Trials Programme Manager at the Institute of Cancer Research, where she oversaw a programme of breast cancer radiotherapy trials. At UCB Pharma, she worked in Global Clinical Sciences & Operations Innovation, where she led the implementation of decentralised trial technologies, such as eConsent, in international studies.
She has designed and led trials of digital health technologies, and advises digital health companies on clinical safety, medical device regulation, information governance and evidence generation. She has co-authored publications in The Lancet, Trials and a Nature portfolio journal, including work on patient and public involvement in research.
Clinical Safety Officer input is provided by a named registered clinician for each engagement.
CONTACT
Talk to us about your product
Talk to us about your product
To discuss a new product, a current project or ongoing support, please contact Liba Stones.
liba@carolaconsulting.co.uk
+44 7443 940319
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