Below are our courses oriented to Medical Devices. To see a complete listing of all training and educational courses we offer, please download our Education Catalog. 

ASQ Certification Academies

  1. ASQ Certified Quality Auditor
  2. ASQ Certified Biomedical Auditor
  3. ASQ Certified Quality Inspector Academia
  4. ASQ Certified Quality Engineer

Investigations and Effective CAPA Systems

  1. Investigation and Effective CAPA Systems Certification
  2. CAPA Effectiveness
  3. Root Cause Analysis, CAPA, and Compliance Writing
  4. Effective CAPA Systems Management Overview

Human Error Investigation and Prevention

  1. Human ERROR Certification
  2. Overview of Human Error

Regulations and Standards

  1. Medical Device Quality System Expert Certification
  2. 21 CFR 820
  3. Understanding Combination Products for Medical Device Manufacturers
  4. ISO 13485-2016
  5. ISO 9001-2015

Auditing Techniques

  1. Internal Auditing Workshop
  2. FDA Inspection Readiness for Medical Device
  3. Auditing Medical devices


Technical and Compliance Writing

  1. How to Write Effective CAPA Investigation Reports
  2. Effective Compliance Writing


Risk Management

  1. Quality Risk Management Certification
  2. Practical FMEA for the FDA-Regulated Industry



  1. Analyzing and Trending Data
  2. Basic Applied Statistics with Minitab
  3. Sampling Best Practices for the FDA-Regulated Industry
  4. Design of Experiments


Lean and Six Sigma

  1. Poka-Yoke
  2. 5S
  3. Six Sigma Green Belt certification



  1. Computer System Validation for the FDA-Regulated Industry
  2. Validation Overview
  3. Cleaning Validation Lifecycle
  4. Facilities and Critical Utilities Systems Qualification
  5. Laboratory Equipment Qualification
  6. General Concepts of Thermal, Radiation, Chemical and Filtration Sterilization Validation
  7. Test Method Validation



  1. Data Integrity Certification
  2. How to Write Procedures and Work Instructions to Reduce Human Errors
  3. Supplier Certification Program
  4. Medical Device Design Controls
  5. Change Control Systems
  6. Best practices on complaint handling for medical devices

Training Program

  1. Train the Trainer
  2. How to Measure Training Effectiveness

Organizational Behavior

  1. Decision Making
  2. Critical Thinking

Employee development

  1. Certification for Medical Devices Operators
  2. Certification for Medical Devices Managers and Supervisors


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