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Quality Audits for the Medical Device Industry Conference (Washington, DC, United States - January 25-26, 2018) - Research and Markets
[November 22, 2017]

Quality Audits for the Medical Device Industry Conference (Washington, DC, United States - January 25-26, 2018) - Research and Markets


The "Quality Audits for the Medical Device Industry" conference has been added to Research and Markets' offering.

Quality management systems of medical devices have to go through well-defined quality audits. Medical device companies need to implement these in order to show compliance with quality.

ISO 13485 is the quality management standard for medical devices. Based on the process approach of this document and that of 21 CFR part 820 the Global Harmonization Task Force (GHTF) has set out processes for audits relating to the quality management systems of medical devices. The GHTF believes that insertion of quality management system requirements based on ISO 13485 is a first step towards global harmonization of medical devices. These guidelines are mant to lead regulators into articulating regulatory systems for medical devices.



Purpose of Quality Audits according to GHTF

  • Assurance that a high quality medical device will be made available
  • Quality audits for the medical device industry make available a harmonized, consistent standard that can be used by future generations
  • These audits are independent, verifiable and objective assessment of the manufacturer's compliance with regulatory requirements
  • The results of these audits can serve as an important guide for marketing medical devices.

Definition of a Quality Audit


GHTF describes the quality audit as the organizational responsibilities, processes, structure, resources and procedures taken to implement a quality management system.

What should the quality management system cover?

  • Control of documents
  • Control of records
  • Management review
  • Internal audits
  • Corrective and preventive action

For more information about this conference visit https://www.researchandmarkets.com/research/xgbl8w/quality_audits


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