Below, you’ll find a collection of resources I’ve gathered over my 8+ years of experience as an engineer in the medical device industry.
Contents
General
Regulatory
Physics and Mechanics
Mechanical Engineering
CAD and Technical Drawing
Material Science
Electrical Engineering
Software Engineering
Usability, Human Factors, UI/UX
Statistics
Manufacturing Methods
Packaging and Labeling
General
Greenlight Guru Resource Hub
Thought leadership on the medical device lifecycle
Total Product Life Cycle for Medical Devices
FDA Guidance
A Guide for Medtech Professionals
Medical device design and development
Reliable Design of Medical Devices
My notes on the book by Richard Fries
Design Controls for the Medical Device Industry
Marie B. Teixeira
Engineering Essentials
Learning resources focused on modeling and design
Engineers Edge
A collection of white papers and resources across disciplines
Engineering ToolBox
Tools and information for engineering and design
Problem Solving Techniques
Root cause analysis tools
Reliability Engineer Body of Knowledge
ASQ CRE
Supplier Quality Engineer Body of Knowledge
ASQ SQE
Ergonomics Core Competencies
Board of Certification in Professional Ergonomics
Regulatory
Overview of Medical Device Regulation
FDA Guidance
Medical Device Quality Management System Overview
Simpler QMS
Selecting and Preparing the Correct Premarket Submission
FDA Guidance
ISO 13485
Medical devices – Quality management systems
21 CFR 820
FDA Medical Device Quality System Regulation
IEC 60601
Medical electrical equipment – basic safety, essential performance
ISO 10993
Biological evaluation of medical devices
IEC 62304
Medical device software life cycle process
ISO 14971
Application of risk management to medical devices
Differences between DHF, DMR, and DHR
Sci Life
Physics and Mechanics
Physics
Khan Academy
Engineering ToolBox – Sound Pressure
What is sound pressure?
Global O Ring
What is durometer (shore durometer)?
Mechanical Engineering
National Eng. Fasteners
Machine Screw Guide PDF
Engineering ToolBox
Succinct reference table for US Machine Screws
WikiHow
How to read a screw thread callout
CAD and Technical Drawing
Engineering Essentials
Drawing Screw Threads
SOLIDWORKS Certification Programs
Curriculums for CAD modeling proficiency
Material Science
Basics of Biocompatibility
FDA Guidance
Parts Badger
Types of brass available for CNC machining
Materials for Medical Devices
White paper on materials for medical devices
Durometer Shore hardness scale
Visual scale with examples
Electrical Engineering
Khan Academy Electrical Engineering
A crash course in the basics
Arduino Project Hub
Creative electrical and computer engineering projects
PBS Learning
How does a fuse work?
Software Engineering
Introduction to Medical Device Software
My notes on the Coursera course given by Xenophon Papademetris
Software Validation for Medical Devices
Medical Device Academy on YouTube
What is IEC 62304?
Medical Device Academy on YouTube
Usability, Human Factors, UI/UX
Handbook of Usability Testing
My notes on the book by Jeffrey Rubin and Dana Chisnell
Applying Human Factors in Medical Device Development
FDA Guidance Document
UX Design Process: Everything You Need to Know
Adobe
Usability Testing Template
Yale University
Meet the Ipsums
Placeholder text
Apple&Banana
Pragmatic UX research resources
Statistics
Design of Experiments
DATAtab YouTube – simply explained
Test Method Validation
White paper from HCL
Verification Concepts and Principles
NASA summary paper
Gage R&R
Repeatability and Reproducibility
ANOVA (Analysis of Variance)
Summary from Investopedia
Excel for Engineering Professionals
LinkedIn Course
Minitab
Education hub for a common statistical software
MATLAB
Online training courses
Manufacturing Methods
Composite Design and Manufacturing: Process and Materials
LinkedIn Course
Packaging and Labeling
Introduction to Medical Device Labeling
FDA Guidance
Sterilization Process Controls
FDA Guidance
Uncovering Medical Device Packaging Requirements
Plastic Ingenuity
Ishmam Ahmed 