SOFTWARE AS MEDICAL DEVICE
Abstract
The use of software in a medical device allows the manufacturer to concentrate on the application needed to run device-specific functions. The medical device manufacturer using software generally neglect software life cycle control, but still bears the responsibility for the continued safe and effective performance of the medical device. Software created for medical purposes and non-medical purpose is being used in healthcare. Earlier, hardware was more important; but in the recent times software one of the element for overall implementation has surpassed the prominence than hardware. Software is vital for the design, architecture and functionally of medical devices. Regulatory bodies have taken approaches in developing definitions and frameworks for software that have common public health goals, with variations in approach. Regulatory guidelines from such regulatory bodies for medical software established and implemented, serves as an environmental scan to provide direction on the guidelines on proposed regulatory framework for adoption, based on best practices. Medical software regulation is aimed to facilitate member economies to establish and harmonize an economic and effective approach for control of medical software in the interest of public health, in the continued innovation of medical software development.
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References
http://ec.europa.eu/health/medical-devices/files/meddev/2_1_6_ol_en.pdf.
2. Standalone Medical Device Software Working Group, IMDRF. Standalone Medical Device Software: Key Definitions [Internet]. 2013 Jun 7 [Cited 2016 Mar 1] Available from:
http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-sskd-130701.pdf.
3. European Commission. Proposal for a Regulation of the European Parliament and of the Council on Medical Devices, and amending Directive 2001/83/EC, Regulation (EC) No 471 178/2002 [Internet]. 2012 Sept 26 [Cited 2016 Mar 25]. Available from: http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf.
4. European Commission. Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices [Internet] 2012 Sept 26 [Cited 2016 Mar 25] Available from:
http://ec.europa.eu/health/medicaldevices/files/revision_docs/proposal_2012_541_en.pdf
5. European Commission. GREEN PAPER on mobile Health ("mHealth") [Internet]. 2014 Apr 25 [Cited 2016 Feb 05] Available from:
http://ec.europa.eu/digital-agenda/en/public-consultation-green-paper-mobile-health.
6. Medical device Software – Software life cycle processes, IEC 62304:2006. s.l.: 481 International Electrotechnical Commission; 2006.
7. Health software - Part 1: General requirements for product safety, IEC/CD 82304-12. s.l.: International Electro technical Commission; 2013.
8. U.S. Department of Health and Human Services Food and Drug. Mobile Medical Applications, Guidance for Industry and Food and Drug Administration Staff. US FDA website [Internet]. 2013 Sept 25 [Cited 2016 Mar 25]. Available from:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf.
9. John F. Murray Jr., CDRH Software Compliance Expert, US Food & Drug Administration. CDRH Regulated Software: An Introduction [Internet]. 2011 Jan 13 [Cited 2016 Mar 11]. Available from:
http://www.fda.gov/Training/CDRHLearn/ucm209135.htm.
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