ISO/TR 27809:2007
Health Informatics - Measures for Ensuring Patient Safety of Health Software
ISO/TR 27809:2007 considers the control measures required to ensure patient safety in respect to health software products. It does not apply to software which is:
- Necessary for the proper application of a medical device;
- An accessory to a medical device; or
- A medical device in its own right.
ISO/TR 27809:2007 applies to any health software product and is addressed to the manufacturers of health software products.
This is only an overview/extract of the standard. Users should not rely on its accuracy, but should refer to the complete standard of the appropriate revision.
Click here for full list of Standards and Regulations.
or call (North America) +1 (877) 876 3430 or (Europe) +44 (0)1795 479001
Proquis Enterprise
Achieve comprehensive quality management with our web-based modular solution for Document Control, CAPA Management, Audit Management, reporting and analysis.
Proquis On Demand
Proquis On Demand offers much of the same robust functionality of our Proquis Enterprise Suite, but is available as a monthly Software as a Service (SaaS) subscription, providing fast implementation, easy scalability, and continuous IT support.
Allclear Process Mapping
Improve business productivity and efficiency with the new Allclear 2010 – A complete process mapping and analysis tool.
