Medical software (English Wikipedia)

Becchetti, C.; Neri, A. (2013). "Chapter 6: Medical Software". Medical Instrument Design and Development: From Requirements to Market Placements. Chichester, U.K.: John Wiley & Sons Ltd. pp. 359–418. ISBN 9781119952404.
Vogel, D.A. (2011). "Chapter 3: The FDA Software Validation Regulations and Why You Should Validate Software Anyway". Medical Device Software Verification, Validation, and Compliance. Boston, MA: Artech House. pp. 27–36. ISBN 9781596934238.
Jetley, R.; Sudarsan, S.; R., Sampath; Ramaswamy, S. (2013). "Medical Software - Issues and Best Practices". Distributed Computing and Internet Technology: 9th International Conference, ICDCIT 2013, Bhubaneswar, India, February 5-8, 2013, Proceedings. Hyderabad, India: Springer. pp. 69–91. ISBN 9783642360718.
"Radar and Electronics". Radar and Electronics Association. March 1963. Retrieved 26 April 2016.
Lockheed Hospital Information System. Lockheed Aircraft Corporation. 1965. p. 82.
Gall, John E.; Norwood, Donald D.; El Camino Hospital (1977). Demonstration and evaluation of a total hospital information system. NCHSR research summary series. U.S. Dept. of Health, Education, and Welfare, Public Health Service, Health Resources Administration, National Center for Health Services Research. p. 38.
Zimmerman, J.; Rector, A. (1978). Computers for the Physician's Office. Forest Grove, OR: Research Studies Press. p. 305. ISBN 0893550078.
Freedman, E.; Hecht, E.; Whiteside, D. (1985). "Consultants Perspective on Medical Office Computerization". Computers in Healthcare, Volume 6. Englewood: Cardiff Publishing Company.
Rust, P.; Flood, D.; McCaffery, F. (2015). "Software Process Improvement and Roadmapping – A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software". In Rout, T.; C'Connor, R.V.; Dorling, A. (eds.). Software Process Improvement and Capability Determination. Cham, Switzerland: Springer. pp. 19–32. doi:10.1007/978-3-319-19860-6_3. ISBN 9783319198606.

doi.org

Cosgriff, P.S. (1994). "Quality assurance of medical software". Journal of Medical Engineering & Technology. 18 (1): 1–10. doi:10.3109/03091909409030782. PMID 8006924.
Yetisen, A.K.; Martinez-Hurtado, J.L.; Vasconcellos, F.C.; Simsekler, M.C.E.; Akram, M.S.; Lowe, C.R. (2014). "The regulation of mobile medical applications". Lab on a Chip. 14 (5): 833–840. doi:10.1039/C3LC51235E. PMID 24425070.
Rust, P.; Flood, D.; McCaffery, F. (2015). "Software Process Improvement and Roadmapping – A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software". In Rout, T.; C'Connor, R.V.; Dorling, A. (eds.). Software Process Improvement and Capability Determination. Cham, Switzerland: Springer. pp. 19–32. doi:10.1007/978-3-319-19860-6_3. ISBN 9783319198606.

embedded.com

Jones, P.; Jetley, R.; Abraham, J. (9 February 2010). "A Formal Methods-based verification approach to medical device software analysis". Embedded. UBM. Retrieved 26 April 2016.

europa.eu

eur-lex.europa.eu

"Directive 2007/47/ED of the European Parliament and of the Council" (PDF). Official Journal of the European Union. European Union. 5 September 2007. Retrieved 26 April 2016.

fda.gov

Office of Device Evaluation, Center for Devices and Radiological Health (9 September 1999). "Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices" (PDF). U.S. Food and Drug Administration. Archived from the original (PDF) on November 29, 2015. Retrieved 26 April 2016.
Center for Devices; Radiological Health (11 May 2005). "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". U.S. Food and Drug Administration. Archived from the original on February 8, 2015. Retrieved 26 April 2016.
Murray Jr., J.F. (March 2010). "CDRH Regulated Software: An Introduction" (PDF). U.S. Food and Drug Administration. Archived from the original (PDF) on July 4, 2011. Retrieved 26 April 2016.
"Quality System (QS) Regulation/Medical Device Good Manufacturing Practices". U.S. Food and Drug Administration. 30 June 2014. Archived from the original on June 4, 2009. Retrieved 26 April 2016.

fiercemobilehealthcare.com

Slabodkin, G. (20 November 2013). "Congress, FDA at odds over software as a medical device". Fierce Mobile Healthcare. Questex, LLC.

fr.com

"New FDA Draft Guidance Sheds Light On Regulation of 'Mobile Medical Apps' and Other Software" (PDF). Medical Devices Law & Industry Report. 5 (16): 1–3. August 2011. Archived from the original (PDF) on 27 November 2013. Retrieved 26 April 2016.

healthit.gov

"HITECH Act of 2009".

iec.ch

webstore.iec.ch

International Electrotechnical Commission (2006). "Medical device software – Software life cycle processes" (PDF). International Standard IEC 62304, First Edition 2006-05. International Electrotechnical Commission. Retrieved 26 April 2016.

imdrf.org

Spanou, D. (9 December 2013). "Software as a Medical Device (SaMD): Key Definitions" (PDF). International Medical Device Regulators Forum. p. 9. Retrieved 26 April 2016.

labsexplorer.com

"Technology in healthcare: how software improves medical practice?". Labs Explorer. Retrieved 5 May 2020.

nih.gov

pubmed.ncbi.nlm.nih.gov

Cosgriff, P.S. (1994). "Quality assurance of medical software". Journal of Medical Engineering & Technology. 18 (1): 1–10. doi:10.3109/03091909409030782. PMID 8006924.
Yetisen, A.K.; Martinez-Hurtado, J.L.; Vasconcellos, F.C.; Simsekler, M.C.E.; Akram, M.S.; Lowe, C.R. (2014). "The regulation of mobile medical applications". Lab on a Chip. 14 (5): 833–840. doi:10.1039/C3LC51235E. PMID 24425070.

raps.org

Mezher, M. (8 April 2015). "IMDRF Proposes QMS Principles for Software as a Medical Device". Regulatory Focus. Regulatory Affairs Professionals Society. Retrieved 26 April 2016.

smartclinics.com.au

"Doctors near me".

web.archive.org

Office of Device Evaluation, Center for Devices and Radiological Health (9 September 1999). "Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices" (PDF). U.S. Food and Drug Administration. Archived from the original (PDF) on November 29, 2015. Retrieved 26 April 2016.
Center for Devices; Radiological Health (11 May 2005). "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". U.S. Food and Drug Administration. Archived from the original on February 8, 2015. Retrieved 26 April 2016.
Murray Jr., J.F. (March 2010). "CDRH Regulated Software: An Introduction" (PDF). U.S. Food and Drug Administration. Archived from the original (PDF) on July 4, 2011. Retrieved 26 April 2016.
"New FDA Draft Guidance Sheds Light On Regulation of 'Mobile Medical Apps' and Other Software" (PDF). Medical Devices Law & Industry Report. 5 (16): 1–3. August 2011. Archived from the original (PDF) on 27 November 2013. Retrieved 26 April 2016.
"Quality System (QS) Regulation/Medical Device Good Manufacturing Practices". U.S. Food and Drug Administration. 30 June 2014. Archived from the original on June 4, 2009. Retrieved 26 April 2016.