4S DAWN Clinical Software is committed to providing products and customer service that meet the highest quality expectations and standards.
We have identified the processes necessary to ensure that both product and service conforms to customer requirements.
As a means of implementing and demonstrating the defined processes, 4S DAWN has established a business management system (BMS) covering the requirements of the following safety standards:
ISO 13485: Medical Devices – Quality management systems, requirements for regulatory purposes
The design, development and maintenance of software solutions for improving decisions and process efficiency with associated support and training services primarily for use in healthcare, science and business applications.
We hold Class 1 CE Mark registrations with the UK MHRA for Anticoagulation Dosing Software and Clinical Decision Support software, which is in accordance with the following Directives:
93/42/EEC The Medical Devices Directive and its amending directives with reference to the following documents:
|Ref No.||Title||Edition / Date|
|EN ISO 14971||Medical Devices – Application of risk management to medical devices||2009|
|EN ISO 13485||Medical Devices – Quality management systems, requirements for regulatory purposes||2009|
ISO 27001:2013 – Information Security
The management of security activities (in the sales, implementation, training, support, general management and administration functions) associated with the supply of software solutions primarily for use in healthcare, science and business