A Clinical Safety Officer (CSO) is a registered clinician / professional who has undertaken clinical risk management training, the mandated standards requires a CSO to review and sign off the related clinical documentation set and have ongoing involvement in the product or project.
This is where there are challenges, the standards require a CSO but it is recognised GP practices, ICS’s, ICB’s and Social Care may not have this role in situ. Therefore, this is where DigiSafe can help provide the expertise and accreditation required.
As well as ensuring compliance with the document set having a named, responsible CSO is key to ensuring continual hazard identification, analysis and mitigation control. As well as any incident reviews which may be required. The retainer service is perfect for this need.
We can provide consultancy at any level whether that be refresher training or new to the world of clinical safety, continual knowledge growth, techniques and best practice sharing is key to ensuring safe, accurate and a confident approach by all. For accredited Clinical Safety training we can offer FCI approved CPD courses through our associates.
This is tricky to answer as it is dependant per client and the technical file/documentation available to support information gathering. The best option is to arrange a call to discuss requirements.
Our team of experts at DigiSafe specialises in guiding software manufacturers through their DTAC compliance journey.
We offer a range of services designed to streamline the compliance process and enhance the overall quality of your digital health solutions.
