Quality & Compliance
Quality is at the heart of everything we do here at 4S DAWN. Ensuring our products are robust, fit for purpose and extremely useful is our obsession, underpinned by friendly and responsive customer service.
We work hard to ensure DAWN software provides safer, more efficient and easier patient high risk medication management.
Our commitment to ongoing quality improvement means we maintain the following standards:
ISO27001: Information Security Management System
This externally audited standard ensures our processes maintain the confidentiality, integrity, and availability of the data we use and have access to.
ISO 13485: Quality Management System
This externally audited standard demonstrates our ability to provide safe medical device software and related services that consistently meet customer demands and applicable regulatory requirements.
UK Cyber Essentials and UK Cyber Essentials Plus
Compliance with these UK Government backed, industry-led standards demonstrates our commitment to cyber security and helps guard against online security threats.
UK MHRA / UK CA Mark
Under the UK Medicines and Healthcare products Regulatory Agency regulation DAWN software is deemed a Class 1 medical device. DAWN software meets this requirement and holds the required UK CA Mark.
EU MDR / CE Mark
Under the European Medical Device Regulation our software is deemed a Class 2a medical device which requires that a technical file for the application is prepared and audited by an external notified body. This certification must be in place by 2028 to supply DAWN software into the EU, and we are currently working towards meeting this requirement.
NHS Data Security and Protection Information Toolkit
Due to the nature of our work, our organisation from time-to-time will have access to NHS patient data. We use the Data Security and Protection Toolkit to publish the outcomes of an assessment against the National Data Guardians 10 data security standards. On each of the last four assessments we have exceeded the required standard. Our organisation code is available on request.
NHS Safety Case and Hazard Logs
The NHS Digital Safety Standard DCB0129 requires us to undertake structured assessments of the clinical safety of DAWN software applications. The clinical safety case reports for the applications evidence that the required safety and documentation requirements have been met. There are always hazards associated with using software in clinical settings. The hazard logs for the DAWN applications outline and categorise these risks. Both the safety case and hazard logs documents are available on request.
