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Software Development for Medical Device Manufacturers

A Comprehensive Two Day Course

Many medical device manufacturers find it difficult to develop software in compliance with FDA QSR regulations, guidance documents, and international standards such as ISO-14971, IEC-62304 and other emerging standards. This two-day comprehensive course provides practical guidance and recommendations for a software development process that complies with FDA QSR, 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 Regulations, guidance documents and standards from the medical device software perspective. Specifically, the course includes an in-depth discussion how Design Controls are interpreted by FDA for medical device software and how to meet the requirements of IEC-62304.

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
  • Design Transfer
  • Design Changes
  • Design History File

Validation of Software Development Tools
  • Creating an inventory of software tools used in development
  • A risk-based approach to software tool validation...

Validation of Software Used in Manufacturing and Quality Systems
  • Creating an inventory of software-based systems used in Manufacturing
  • A risk-based approach to validation...
  • Creating an inventory of software applications used in Quality Systems
  • A risk-based approach to validation...

Risk Management for Software-based Medical Devices
  • Terms and Concepts
  • Risk Management Process
  • Risk Management Tools and Techniques
  • Fault Tree 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.

I frequently review a client’s Quality Manual and relevant SOPs in advance. This way, I can prepare a brief assessment of your current Quality System and how it meets (or doesn't meet) the regulations and standards which can then be discussed as part of the course.
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