Software Development for Medical Device Manufacturers – On-Line Course

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Software Development for Medical Device Manufacturers

A comprehensive online course – 180 days to access course

Developing software in compliance with FDA, EU regulations and international standards is challenging. This comprehensive 4+ hour online course provides practical guidance and suggestions for developing software that complies with applicable FDA and EU regulations, FDA Guidance documents and international standards such as IEC 62304 and ISO 14971. The focus of this course is interpreting FDA Design Controls for software. Each section of the Design Controls regulation (21 CFR Part 820.30) is discussed from the software perspective. Corresponding requirements from IEC 62304 are woven into the discussion.

In-depth discussion of critical topics such as Requirements, Software Verification & Validation, Risk Management and Fault Tree Analysis are included. In addition, techniques for validating software development tools and software used in Manufacturing and Quality Systems are also discussed.

Comprehensive reference materials are available by requesting a DropBox link.


Software and firmware engineers, software managers, RA/QA staff, validation engineers, and project managers. Anyone interested in learning how to develop medical device software in compliance with regulations, standards and guidance documents.


  • Modules 1, 2, 3 (approx. duration 2 hours)
    • Medical Device Definitions – FDA and EU
    • Regulatory Roadmap and FDA/EU Device Classification Schemes
    • FDA Regulations and Guidance Documents for Software
    • Standards – ISO 13485, IEC 62304, ISO 14971, EN-14971 and IEC 62366-1
    • All Software is Defective
    • Summary
  • Module 4 – Interpreting Design Controls for Software (approx. duration 1.5 hours)
    • Software Development Models
    • Design and Development Planning
    • Design Inputs
      • About Requirements…
    • Design Outputs
    • Design Reviews
    • Design Verification
      • Software Verification Techniques
    • Design Validation
      • Software Validation Process
    • Design Transfer
    • Design Changes
    • Design History File
    • Summary
  • Module 4 – Validation of…
    • Software Tools used to develop Medical Device Software
    • Software used in Manufacturing
    • Software used in Quality Systems
  • Module 5 – Risk Management (approx. duration 1 hour)
    • Standards and Regulations
    • Terms and Concepts
    • Risk Management Process
    • Risk Management Tools and Techniques
    • Pre and Post-release Data Collection and Analysis
    • Documentation Requirements
    • Summary

Course Fee Schedule: Registration is On-Going

Cost: $220

Refund Policy:  No refunds for online courses once the course is accessed by the attendee