Get the clinical, regulation and compliance support you need for your Digital Clinical Products
Transforming Digital Clinical and Safety support
We support companies that place 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.
A modern and agile approach
It’s essential for us that our clients get personalised support. Our system is flexible and designed support your needs. Removing all the heavy compliance documentation away so you can focus on building innovative products.
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.
“I founded Digital Clinical Safety because governance can be perceived to stifle innovation. My goal is to help incredible health technology teams to build fast and deploy safely. Allowing teams to focus on building the best technology for their patients.”
Dr Yasmin Karsan, MRPharmS, PhD, MSc, PGCert
Founder of Digital Clinical Safety