The CMDA Primer 1st edition 2020 contains 780 pages. The electronic exam currently contains 1000 questions.
Digital Material is also available Click Here to go to our digitals page.
I. Certification Overview
- Certified Medical Device Auditor Exam
- CMDA Body Of Knowledge
- 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
- Data Privacy
- 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
- Data Integrity
- 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
- ISO 19011 SYNOPSIS
- IMDRF
- MDSAP
- 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
- ISO 9001
- ISO 13485
- ISO/IEC 17025
- GHTF.SG3.N99-10
- References
V. Quality System Regulations
- 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
- Compliant Files
- Servicing
- Statistical Techniques
- Post-market Surveillance
- References
VI. Biomedical Knowledge Part I
- Risk Management
- ISO 14971
- IEC 63266
- ISO 13485 (Risk)
- Design Control
- Human Factors
- Biological Evaluation
- Packaging
- Device Shelf Life
- General Safety Requirements
- Software Development
- Labeling
- References
VII. Medical Device Knowledge Part II
- Controlled Environments
- Utility Systems
- Sterile Medical Devices
- Sterilization Methods
- Laboratory Testing
- Validation
- Reprocessing And Cleaning
- Medical Device Directives
- ISO 60601
- ISO 80001
- Rohs
- Reach
- New And Evolving Standards
- References
VIII. Quality Tools & Techniques
- Quality Control & Problem Solving Tools
- Checklists/Checksheets
- Flow Charts
- Scatter Diagrams
- Cause & Effect Diagrams
- Pareto Diagrams
- Histograms
- Control Charts
- Root Cause Analysis
- Plan/Do/Check/Act
- Brainstorming
- 5 Whys
- Kepner-Tregoe
- Alert And Action Limits
- Process Improvement Techniques
- Process Capability
- Six Sigma
- Lean Tools
- MSA
- Cost Of Quality
- Data Types & Sampling
- References
IX. Biomedical Standards
X. Appendix/Index
- Medical Device Definitions
- Name Index
- Subject Index
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