WHY TRAIN WITH VELOCITY 360?

Certified Provider.
Quality-Assured Training.

Velocity 360 training products are developed within our ISO 9001:2015 quality management system, certified by NQA, an ANAB-accredited certification body. We are also an Exemplar Global Certified Training Provider for select training programs.

Exemplar Global, NQA ISO 9001 and ANAB accreditation credentials

Program Overview

This four-course program develops practical competencies for conducting ISO 13485:2016 medical-device QMS internal audits, applying ISO 14971:2019 risk management requirements, strengthening documentation and data integrity, and using FMEA to identify and control product and process risks.

Designed for medical-device quality managers, internal auditors, regulatory professionals, engineers, manufacturing professionals, and compliance personnel responsible for ISO 13485 implementation, medical-device risk management, documentation control, and continual improvement.

What This Program Helps You Do

Interpret ISO 13485:2016 medical-device QMS requirements and conduct risk-based internal audits using ISO 19011:2026 guidance.
Apply ISO 14971:2019 requirements to identify, evaluate, control, and monitor medical-device risks.
Evaluate documentation and data integrity using Good Documentation Practice and ALCOA+ principles.
Use FMEA to identify, assess, and reduce product and process risks.

Courses Included

ISO 13485:2016 Internal Auditor

This On-Demand, 24-hour e-course provides practical instruction in ISO 13485:2016 medical device QMS requirements and ISO 19011:2026 guidance for conducting internal audits. Includes a Certificate of Competence. 2.4 CEUs. Language: English.

ISO 14971:2019 Requirements

This On-Demand, 6-hour e-course provides practical instruction in the concepts, requirements, and best practices of ISO 14971:2019 medical device risk management. Includes a Certificate of Competence. 0.6 CEUs. Language: English.

Good Documentation Practice and Data Integrity (ALCOA+)

This On-Demand, 4-hour e-course provides practical instruction in Good Documentation Practice and the ALCOA+ principles of data integrity. Includes a Certificate of Competence. 0.4 CEUs. Language: English.

Failure Mode and Effects Analysis (FMEA)

This On-Demand, 4-hour e-course provides practical instruction in the seven-step FMEA methodology, risk analysis, rating criteria, Action Priority, and auditing FMEA effectiveness. Includes a Certificate of Competence. 0.4 CEUs. Language: English.

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Program Highlights
  • 4 Quality-Assured Courses
  • On-Demand and Self-Paced
  • 38 Training Hours
  • 3.8 CEUs
  • Language: English
  • 4 Certificates of Competence
  • Save $1,385 (46%) versus Individual Prices
Enrollment Benefits:
  • Immediate access after enrollment
  • 12 months of unlimited access—even after completion
  • Certificates issued immediately upon completion
  • No added exam or certificate fees