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Software Development for Medical Device Manufacturers

A Comprehensive Two Day Course

Many medical device manufacturers struggle to develop software in compliance with FDA/EU regulations, FDA Guidance documents, and international standards such as ISO 14971, IEC 62304 and IEC 62366. This two-day comprehensive course provides practical guidance and recommendations for a software development process that complies with FDA/EU regulations, FDA Guidance documents, applicable international standards in a manner that is flexible, cost-effective, and makes good business sense.

The focus of this two-day course is on interpreting FDA/EU Regulations, FDA Guidance documents and standards from the software perspective. Specifically, the course includes an in-depth discussion how Design Controls and ISO 62304 requirements are interpreted for medical device software. Also covered in depth are the requirements for Risk Management based on ISO 14971.

Topics covered:

  • FDA Regulations and Guidance Documents
  • EU Medical Device Regulations
  • International Standards
  • Quality System Overview - Procedures, Work Instructions and Records
  • All Software is Defective...

Interpreting Design Controls for Software
  • Design Controls and IEC 62304 Requirements
  • General Requirements
  • Design and Development Planning
  • Software Development Models
  • Design Input
  • About Requirements...
  • Requirements Exercise
  • Design Output
  • Design Reviews
  • Design Verification
  • Unit and Integration Testing
  • Static Analysis
  • Design Validation
  • Validation Planning
  • Validation Testing
  • Testing Overview
  • Design Transfer
  • Design Changes
  • Design History File

Validation of Software Development Tools
  • Identifying software tools used in development
  • A risk-based approach to software tool validation

Validation of Software Used in Manufacturing and Quality Systems
  • Identifying software used in Manufacturing and QMS
  • A risk-based approach to software validation

Risk Management for Software-based Medical Devices
  • Terms and Concepts
  • Risk Management Process per ISO 14971
  • Risk Management Tools and Techniques
  • Fault Tree Analysis Exercise
  • Production and Post-Production Data Collection and Analysis
  • Risk Management File Documentation Requirements

 To help reinforce critical skills, two interactive, small-group exercises are included in the course. An extensive set of reference documents is also provided to supplement the course notes.


Courses and seminars can be tailored to meet your specific needs and all are based on the simple principle that real learning occurs when people are actively involved.

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