Extensive focus on compliance
Compliance is a big deal here at Auditdata. We have extensive focus on keeping our solutions up to standard with current national and international regulations and laws.
Auditdata complies with the data protection and privacy laws generally applicable to Auditdata’s business activities. Below is a short mention of AuditBase compliances, however, you can read much more about Auditdata’s full dedication to security, compliance and privacy practices at our Trust center.
Medical device & CE marking
The Auditbase office management system is classified as a Medical Device (Class I) under the EU Medical Device Directive 2007/47/EC1.
The Auditbase product from version 4.19.3 and forward is CE-marked and registered with the Danish Health and medicines Authority.
Directive 2007/47/EC1 amended the definition of the term “medical device” used in Directives 90/385/EEC2 and 93/42/EEC3 by February 2010.
Directive 2007/47/EC states: “it is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device. Standalone software for general purposes when used in a healthcare setting is not a medical device.”
Assessing the AuditBase product against the decision tree of Directive 2007/47/EC1, concludes that the product should be covered by the medical device directive:
- Categorized as: “Hospital Information System”
- For storage and transfer of electronic patient records, archiving of documents and data related to a specific patient.
- Incl. Audiogram & Auditory Implant modules for recording, viewing and changing of clinical patient data.
- A connected Audiometer is a medical device min. Class IIa
- Including its Audiometer Control Panel
- Including the use of the AuditBase Audiogram Module
Product development compliance
The AuditBase product development is covered by the Auditdata Quality Management System, certified in accordance with ISO/IEC 13485 QMS for Medical Devices and the Information Security Management System, certified in accordance with ISO/IEC 27001.
The product development process is in compliance with:
- ISO/IEC 62304 Software Development Life Cycle
- ISO/IEC 14971 Medical Device Risk Management
The AuditBase product is compliant to NHS standards, such as:
- DSCN14/2009 & ISB 0129
- “Patient Safety Risk Management System – Manufacture of Health Software”
- DSCN18/2009 & ISB 0160
- “Guidance on the management of clinical risk relating to the deployment and use of health software”
Any software product that is regulated as a medical device and whose manufacture is in compliance with ISO 14971, can be considered as in compliance with DSCN14/2009 & ISB 0129 with the addition of:
- 4.6 – to compile a clinical safety case
- Clause 8 – to make available a clinical safety case report to a customer or regulatory authority
- Clause 11 – to undertake necessary steps to identify any differences in risk when a product is modified
A Clinical Safety Case Report for AuditBase System (Version 4.19.3+) is available on request by Auditdata NHS Customers at firstname.lastname@example.org.
DSCN18/2009 & ISB 0160 – “Guidance on the management of clinical risk relating to the deployment and use of health software” is the responsibility of the data and system owner. The AuditBase Clinical Safety Case Report can be provided by Auditdata to support the customers need for product risk assessment in the process of fulfilling the requirements of DSCN18/2009 & ISB 0160.
Want to know more?
If you are still not certain about how a clinic management system like Auditbase can help you streamline your clinic – whether it entails one or multiple clinics – you can find out more about Auditbase here. If you are more interested in the technical specifications, please check out our AuditBase product pages.
Still not convinced? Then get in touch and experience AuditBase for yourself.