How software requirements are used in validation will be described

Medical devices are used by millions of people around the world, and an error can result in fatal issues.


The current and expected growth of medical devices, the size of the global market for which is put at around $520 billion annually, and expected to reach nearly $700 billion by 2022, is a cause for cheer for those in the industry. It is, however, also a serious reason to call for scrutiny, since medical devices are used by millions of people around the world, and an error can result in fatal issues.

Of high concern is the aspect of software testing for medical devices, because most of these medical devices are powered by software. Further, some software programs are themselves considered medical devices. The basic purpose of testing software for medical devices is to establish and prove that it works as intended and is free of bugs. However, given the complexity of certain devices and the software that go into them; guarantees at this level are not considered sufficient.

The device has to go beyond proving its fitness for use

If a medical device software has to obtain FDA approval; it should be subjected to additional analyses and tests that the FDA feels are necessary to prevent user injuries. The FDA developed these requirements after thoroughly analyzing many medical devices it had recalled.


This points to the criticality of carrying out software testing for medical devices in a manner that meets the FDA’s requirements. Want to gain this important understanding? A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will put you on the path to understanding what it takes to meet the FDA’s requirements for medical device software.

This webinar is being taught by Edwin Waldbusser, a senior consultant for the medical device industry. Having retired from the industry after over two decades in managing the development of medical devices and having five patents against his name, Edwin has been consulting in the US and internationally in the areas of design control, risk analysis and software validation.

Please register for this webinar by visiting

An understanding of the additional FDA requirements

The requirements of the FDA, that it asks for in addition to the usual testing for software for medical devices, will be explained. This important learning from this webinar will give participants an understanding of the testing that is required in addition to functional tests to produce a validated software product.

The main learning of this course relates to how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. The important learning objective of this course is how to validate medical device software in compliance with FDA objectives. Risk analysis in validation has a key role in this, and Edwin will explain this in detail. He will also describe how software requirements are used in validation.

To reinforce the learning, Edwin will give participants handouts consisting of software traceability matrix form, validation plan template, and validation report form.

Edwin will cover the following areas at this course:

  • Software Validation more than Testing
  • Requirements Traceability
  • Risk Analysis
  • Unit, Integration and System Testing
  • Algorithm Validation
  • Challenges to the Software
  • Configuration Management.

Personnel in charge of medical device software validation, such as Engineering Personnel, Software Developers, QA, and Management will benefit from this course.

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Author: compliance4all

Compliance4All, the ultimate continuing professional education provider offers you regulatory and compliance trainings from the industry's leading experts, but with one crucial difference -the cost. Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits. Industries We Focus On: • Trade & Logistics • Aerospace Defense • Banking & Insurance • Food & Beverages • Auditing/Accounting & Tax • Energy • Environment • Education • Automotive Transport • Science and Technology • Government • Construction • Electronics & Semiconductor • Operation • Engineering/Science • Purchasing & Vendor Relation • General counsel/Accountant • Geology & Mining • Documentation/Records

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