Free Guide to Developing Software Quality SOPs
Are you working to create a compliant quality system for your software development work, but unsure what topics to cover or what to incorporate in each procedure?
ShoeBar Associates has developed and refined these procedures many times, and has distilled that knowledge into a set of thoughts and questions to help you generate the SOPs you need.
To obtain this no-cost resource:
ShoeBar Associates has developed and refined these procedures many times, and has distilled that knowledge into a set of thoughts and questions to help you generate the SOPs you need.
To obtain this no-cost resource:
Standards and Guidance
- Quality System Regulation - background and information
- Design Control Guidance For Medical Device Manufacturers (March 11, 1997); background and general information
- General Principles of Software Validation (January 11, 2002)
- Information: FDA Software Systems Assured Verification research
- Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (draft, December 8, 2017)
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
- Deciding When to Submit a 510(k) for a Software Change to an Existing Device (October 25, 2017)
- Off-The-Shelf Software Use in Medical Devices (Sep. 9, 1999)
- Qualification of Medical Device Development Tools (August 10, 2017)
- Mobile Medical Applications (Sep. 25, 2013)
- Global Approach to Software as a Medical Device
- Software as a Medical Device - Clinical Evaluation (December 8, 2017)
- Clinical and Patient Decision Support Software (draft, December 8, 2017)
- Blood Establishment Computer System Validation in the User’s Facility (April 2013)
- “Computer Crossmatch” (Computerized Analysis of the Compatibility between the Donor’s Cell Type and the Recipient’s Serum or Plasma Type) (April 2011)
- Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software (Jan. 14, 2005)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (draft, October 18, 2018)
- Postmarket Management of Cybersecurity in Medical Devices (December 28, 2016)
- Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices (September 6, 2017)
- Radio Frequency Wireless Technology in Medical Devices (August 14, 2013)
- Computerized Systems Used in Clinical Investigations (May 2007)
- 21 CFR Part 11: Electronic Records and Signatures (Aug. 1997)
- Medical Device Data Systems - Information and link to final rule (Feb. 15, 2011)
- ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes
- IEC 62304: Medical Device Software – Software Life Cycle Processes (note that a corrections / revisions document is also needed for this to be complete)
- ISO 14971: Medical devices – Application of risk management to medical devices
- IEC TIR80002-1: Medical Device Software – Part 1: Guidance on the application of ISO 14971 to medical device software
- AAMI TIR 45: Guidance on the use of AGILE practices in the development of medical device software
- IEEE/ISO/IEC 12207: Information Technology – Software life cycle processes
- IEEE Std 1228, Software Safety Plans
- IEEE/ISO/IEC 16085, Software & Systems Life Cycle Processes- Risk Management (based on IEEE 1540 Software Risk Management)
Recent Software Incidents
February 01, 2019
External monitor / defibrillator: Certain defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.
External monitor / defibrillator: Certain defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.
January 17, 2019
Dual Chamber Implantable Pulse Generators (IPGs) Recalled Due to Possible Circuit Error: a software error can result in a lack of pacing. Patients and physicians cannot predict whether and when this software error might occur. A lack of pacing could result in patients experiencing slow heart beating, low blood pressure, and symptoms such as light headedness, fainting, and even death.
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm631470.htm
Dual Chamber Implantable Pulse Generators (IPGs) Recalled Due to Possible Circuit Error: a software error can result in a lack of pacing. Patients and physicians cannot predict whether and when this software error might occur. A lack of pacing could result in patients experiencing slow heart beating, low blood pressure, and symptoms such as light headedness, fainting, and even death.
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm631470.htm
October 09, 2018
Software defect in stereotactic guide system software when used with specific ports under certain circumstances. When one trajectory is set with a blue port and another trajectory is set with a gold port, the software defect is triggered when the user switches between these trajectories during a surgical procedure.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168201
Software defect in stereotactic guide system software when used with specific ports under certain circumstances. When one trajectory is set with a blue port and another trajectory is set with a gold port, the software defect is triggered when the user switches between these trajectories during a surgical procedure.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168201
September 26, 2018
Cranial depth gauge (Neurological stereotaxic Instrument) recalled: incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167816
Cranial depth gauge (Neurological stereotaxic Instrument) recalled: incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167816
September 24, 2018
Clinical mass spectrometer recalled: Under certain conditions with specific software, it is possible for the original data from the last acquired sample to be over-written when the automatic flush is enabled.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167969
Clinical mass spectrometer recalled: Under certain conditions with specific software, it is possible for the original data from the last acquired sample to be over-written when the automatic flush is enabled.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167969
June 15, 2018
Digital angiographic X-ray system: because of a software issue the C-arm may unexpectedly move when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=167416
Digital angiographic X-ray system: because of a software issue the C-arm may unexpectedly move when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=167416
May 1, 2017
Ventilators recalled because they may shut down spontaneously during normal operation without an accompanying alarm.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154521
Ventilators recalled because they may shut down spontaneously during normal operation without an accompanying alarm.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154521
March 13, 2017
Blood culture system can produce false susceptible results for specific bacterial isolates vs antibiotic meropenem
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171153
Blood culture system can produce false susceptible results for specific bacterial isolates vs antibiotic meropenem
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171153