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Certified Biomedical Auditor Primer
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The CBA Primer 1st edition 2013 contains 648 pages and 400 questions and answers.  The electronic exam currently contains 1000 questions.

Digital Material is also available Click Here to go to our digitals page.

CBA Table of Contents

I. Certification Overview

  • Certified Biomedical Auditor Exam
  • Bloom's Taxonomy

II. Auditing Fundamentals

  • Audit Types
  • Audits by Method
  • Audits by Purpose
  • Audit Roles and Responsibilities
  • Ethical, Legal, & Professional Issues
  • Prof. Conduct & Responsibilities
  • Legal Consequences & Liability
  • References

III. Auditing & Inspection Processes

  • Audit Preparation & Planning
  • Elements of the Planning Process
  • Auditor Selection
  • Audit Related Documentation
  • Auditing Strategies
  • Logistics
  • Audit Performance
  • Opening Meeting
  • Data Collection and Analysis
  • Communication Techniques
  • Analysis of Objective Evidence
  • On-site Audit Management
  • Exit Meeting
  • Audit Reporting
  • Basic Elements
  • Effective Audit Reports
  • Record Retention
  • Audit Follow-up and Closure
  • Corrective & Preventive Action
  • Corrective Action Plan Review
  • Conducting Audit Follow-up
  • Audit Closure
  • Audit Procedural References
  • International Guidelines
  • QSIT
  • FDA CPG 7382.845
  • References

IV. Regulatory Requirements

  • FDA-Code of Federal Regulations
  • U.S. Requirements
  • European Device Directive
  • Health Canada
  • Japan
  • Other International Agencies
  • FDA Guidance for IVD Products
  • International Standards for Quality Systems
  • ISO 9001
  • ISO 13485
  • ISO/IEC 17025
  • GHTF.SG3.N99-10
  • References

V. Quality System Regulation

  • Management Responsibility
  • Design Control System
  • Document & Record Control
  • Purchasing Controls
  • Identification & Traceability
  • Production & Process Controls
  • Nonconforming Product
  • Corrective & Preventive Action
  • Product Handling, Storage, Distribution, & Installation
  • Servicing
  • Statistical Techniques
  • Post-market Surveillance
  • References

VI. Biomedical Knowledge Part I

  • Risk Management
  • ISO 14971
  • IEC 63266
  • Assessment Tools
  • Sterilization
  • Introduction
  • Definitions
  • Methods and Process Control
  • Biocompatibility
  • Control Environments & Utility Systems
  • Controlled Environments
  • Utility Systems
  • References

VII. Biomedical Knowledge Part II

  • Software Product Development
  • Lab Testing & Failure Analysis
  • Sources for New & Evolving Standards
  • Medical Device Directives & Standards
  • Packaging
  • Reuse & Cleaning of Medical Devices
  • References

VIII. Quality Tools & Techniques

  • Quality Control and Prob. Solving
  • Process Improvement Techniques
  • Process Capability
  • Six Sigma
  • Lean Tools
  • Measurement System Analysis
  • Cost of Quality
  • Data Types & Sampling
  • Qualitative and Quantitative Analysis
  • Attribute & Variables Data
  • References

IX. Biomedical Standards

X. Index

  • Biomedical Definitions
  • Name Index
  • Subject Index
  • Answers

View a Sample Section

DIGITAL materials are licensed for use on one computer for a period of two years. The file contents cannot be printed or copied.  The files are compatible with Windows XP, Vista,Windows 7 and Windows 8 only. Installation of the Viewer software requires Administrator rights. The Viewer requires access to the internet at an interval of every 14 days. The license and file access fee is non-refundable. Digital files cannot be installed on a Server, Mac, virtual computer, or viewed via a thin client.

Please note that Digital products are not available for immediate download. Information for installation of the Viewer and file download links will be sent via e-mail normally by the next business day, Monday to Friday, excluding holidays.



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