Medical Device Testing

Master the 62304 standard and FDA design controls

Become Medical Software Testing Expert at any stage of your career.

Phases of medical device development, Medical device safety and compliance, How to train your staff on medical device.

This book provides a reference for people working in the design, development, and manufacturing of medical devices. ​While there are no statistical methods specifically intended for medical devices, there are methods that are commonly applied to various problems in the design, manufacturing, and quality control of medical devices. The aim of this book is not to turn everyone working in the medical device industries into mathematical statisticians; rather, the goal is to provide some help in thinking statistically, and knowing where to go to answer some fundamental questions, such as justifying a method used to qualify/validate equipment, or what information is necessary to support the choice of sample sizes.

To paraphrase a popular saying, usability testing should be done early and often.

Best Practices for Compliance and Safety in Medical Device Software

Embrace regulatory joy of medical device