Excellence beyond compliance : establishing a medical device quality system

Excellence beyond compliance : establishing a medical device quality system /

"Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious k...

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Bibliographic Details
Main Author: White, William I. (Author)
Format: Electronic eBook
Language:English
Published: Boca Raton : CRC Press, Taylor & Francis Group, 2018.
Subjects:
Medical instruments and apparatus > Standards.
Medical instruments and apparatus > Quality control.
Electronic books.
Online Access:Full text (MCPHS users only)
Full text (Wentworth users only)
Table of Contents:
  • Machine generated contents note: ch. 1 Challenge
  • Objective: Good Products
  • Compliance is Fundamental
  • Moving Target
  • Worldwide Requirements
  • United States
  • Canada
  • Europe
  • Latin America
  • Asia
  • Australia
  • Middle East and Africa
  • More Requirements
  • Product Approval/Registration
  • Internal Requirements
  • Exceptions
  • Beyond Requirements
  • Employee Perspective
  • Quality and Regulatory Perspective
  • ch. 2 Path
  • Are We Satisfied?
  • Top Management Support?
  • Steering Committee
  • Key Decisions
  • Establishing the Improvements
  • Maintenance
  • ch. 3 Key Decisions
  • Level of Control
  • Small Company: Straightforward Documentation Structure
  • Large Company: Several Options
  • Single QMS?
  • Choosing Among the Options
  • Framework
  • Customized Framework
  • FDA CGMP Framework
  • FDA QSIT Framework
  • ISO 13485 Framework
  • ISO 9001:2015/Annex SL Framework
  • Essentially Two Choices
  • Choosing Between FDA and ISO Frameworks
  • ch. 4 Quality Plan
  • Background to the Plan
  • Quality Plan
  • Documentation Transitioning
  • Human Resources
  • Quality Council
  • QMS Support Staff
  • Software Infrastructure
  • Approval
  • ch. 5 Documentation, the Big Picture
  • Structure
  • Right Number of Levels
  • Format
  • Cautions
  • Flexibility
  • Language
  • Content
  • Electronic Documentation
  • Covering All Markets
  • Ensuring Full Coverage
  • ch. 6 Level
  • Documentation
  • Quality Policy
  • Content
  • Implementation
  • Translations
  • Quality Manual
  • Look and Feel
  • External Value
  • Challenges
  • ch. 7 Level
  • Documentation
  • Value to the Employee
  • Principles Applicable to Each Process
  • Appendix
  • ch. 8 Level
  • Documentation
  • Corporation-Wide Level 3
  • Complaints
  • Medical Device Reporting/Vigilance
  • CAPA
  • Quality Audits
  • Format
  • Flowcharts
  • Playscript Procedures
  • Language
  • Software
  • Keeping Current
  • ch. 9 Level 4 Documentation
  • Records
  • Forms
  • Guidelines/Guidances
  • Training Materials
  • External Documentation
  • ch. 10 Fully Incorporating Risk Management
  • Quality Manual
  • Level 2
  • Level 3
  • ch. 11 Implementation
  • Communication
  • Resources
  • Human Resources
  • Infrastructure
  • Documentation
  • Training
  • ch. 12 Maintenance (and Improvement)
  • Metrics
  • Internal Audits
  • Many or Few Auditors?
  • Effectiveness
  • Quality Council
  • Management Review
  • Working with Registrars/Notified Bodies
  • Definitions
  • Relationships
  • Value
  • Multiple Sites
  • Developments to Watch
  • Never-Ending Story.

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