QUALITY STANDARDS FOR MEDICAL DEVICES

  • Achin Jain
  • Neenu Ganesh
  • M. P. Venkatesh

Abstract

Formerly with more augmented disabilities, Medical devices have become decisive device in many circumstances. As these are more perilous, the manufacturer should endow with an ideal medical device in aspects of safety & quality. To produce a homogeneous device globally, there should be some standards to be followed within an explicit country and standard throughout the globe, complying with the quality. In milieu of this resemblance of device globally, International Organization for Standard (ISO) has issued a standard, ISO 13485. This article is made to furnish the details about ISO 13485 and the Quality management system followed by United States manufacturer’s to market their devices within the country, i.e., 21 CFR Part 820.

Keywords: Medical devices, ISO 13485, 21 CFR-Part 820.

Downloads

Download data is not yet available.

References

1. U.S. Food and Drug Administration [Internet]. Silver spring, MD; 2012 April [cited 2014 Feb 24] Available from:
http://www.fda.gov/aboutfda/transparency/basics/ucm211822.htm
2. U.S. Food and Drug Administration [Internet]. Silver spring, MD; 2012 Dec [cited 2014 Feb 24] Available from:
http://www.fda.gov/%20MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm (Cited on 2014 Feb 24)
3. PocCENT, point of care Center for Emerging Neurotechnologies [Internet]. USFDA; 2014[cited 2014 Feb 24].
Available from:
http://www.ece.uc.edu/POC-CENT/funding/ Additional%20Information/fda-classification
4. U.S. Food and Drug Administration [Internet]. Silver spring, MD; 2013 April [cited 2014 Feb 24]. Available from:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm2005378.htm (Cited on 2014, Feb 24)
5. ISO, What is a standard? [Internet]. Geneva; 2014 [cited 2014 Feb 24]. Available at:
http://www.iso.org/iso/home/standards.htm.
6. ISO, International Organization for Standard- ization [Internet]. Geneva; 2014 [cited 2014 Feb 24]. Available at:
http://www.standards.org/standards/listing/iso_13485.
7. Willett N. Quality Magazine. Quality Management: The Need for ISO 13485 [Internet]. 2011 Jan [cited 2014 Feb 25]. Available at:
http://www.qualitymag.com/articles/87898-quality-management-the-need-for-iso-13485.
8. U.S. Food and Drug Administration [Internet]. Silver spring, MD; 2014 Jun [cited 2014 Feb 25]. Available from:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/
9. Incra Med, Medical Device Solutions [Internet]. Ireland; 2010 [cited 2014 Feb 25]. Available from:
http://incramed.com/main/page_training_solutions_device_design.html
10. Incra Med, Medical Device Solutions [Internet]. Ireland; 2010 [cited 2014 Feb 26]. Available from:
http://incramed.com/main/page_training_solutions_fda_qsrs.html
11. Incra Med, Medical Device Solutions [Internet]. Ireland; 2010 [cited 2014 Feb 26]. Available from:
http://incramed.com/main/page_training_solutions_capa.html
12. Master Control, Compliance Accelerated [Internet]. Utah; 2014 [cited 2014 Feb 26]. Available from:
http://www.mastercontrol.com/iso13485/ISO_13485_Certification.html
13. 13485 Store [Internet]. US; 2003 Aug 5 [cited 2014 Feb 26]. Available from:
http://13485store.com/downloads/compare-iso-9001-and-iso-13485-to-fda-qsr.pdf.
Statistics
279 Views | 307 Downloads
How to Cite
Jain, A., N. Ganesh, and M. P. Venkatesh. “QUALITY STANDARDS FOR MEDICAL DEVICES”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 4, Feb. 2018, pp. 19-24, doi:10.22270/ijdra.v2i4.149.