Medical device vigilance/monitoring
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Medical device vigilance/monitoring European device directives compliance by Robin N. Stephens

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Published by Interpharm Press in Buffalo Grove, Ill .
Written in English

Subjects:

Places:

  • Europe.,
  • Europe

Subjects:

  • Medical instruments and apparatus -- Defects -- Reporting -- Europe.,
  • Medical instruments and apparatus industry -- Europe -- Quality control.,
  • Medical instruments and apparatus industry -- Safety regulations -- Europe.,
  • Equipment and Supplies -- standards -- Europe.,
  • Equipment Failure.,
  • Equipment Safety -- standards -- Europe.,
  • Quality Control.

Book details:

Edition Notes

Includes bibliographical references and index.

Other titlesMedical device vigilance, monitoring
StatementRobin N. Stephens ; with contributions by Eddie F.J. van Eeckhoven.
ContributionsEeckhoven, Eddie F. J. van.
Classifications
LC ClassificationsR856.6 .S74 1997
The Physical Object
Paginationxvii, 198 p. :
Number of Pages198
ID Numbers
Open LibraryOL1011304M
ISBN 101574910302
LC Control Number96051891
OCLC/WorldCa36051966

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The Provisions for Medical Device Adverse Event Monitoring and Re-evaluation, approved by the State Administration for Market Regulation and the National Health Commission, is hereby promulgatedand shall be put into force as of January 1,   • remove, i.e. recall the medical device or IVD from the market. The Regulatory Authority has established procedures for the ongoing monitoring, vigilance and recall for medical devices and IVDs supplied in South Africa. These guidelines are relevant only to medical devices and IVDs. Separate guidelines apply to the   With over 30 years of experience, the Medical Vigilance Solutions team provides pharmacovigilance and medical communications outsourcing solutions to meet your changing needs. Powered by a staff of highly specialized pharmacists, nurses and allied health professionals, we offer a broad scale of services that fit seamlessly into your process   Do you now the requirements and your responsibilities for medical device vigilance reporting Considerations To support compliance to the vigilance requirements listed in Table 1, it is important to consider the aspects of a quality system (such as ISO ) which allow for the collection of the appropriate information which will /LocalFiles/en-US/Whitepapers/

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