Verification & Testing Strategies for Compliance with ISO 13485:2016, IEC 62304 / 60601-1 / 82304-1

Effective, well-documented verification and testing activities are fundamental for ensuring your product fulfills the necessary compliance requirements.

When done right, you'll have a high quality product development process with reduced mistakes, fewer changes, and accelerated speed.

Compliance with the IEC standards for medical software and hardware, however, tend to be one of the most common sources of confusion for manufacturers.

Having a clear understanding of the international standards which will dictate your verification and testing activities is the only way to ensure compliance and produce a high quality software or hardware medical product.

We've teamed up with Kyle Rose of Rook Quality Systems who will share his expertise on the topic and provide proven tips and strategies your company can start implementing today to ensure compliance with ISO 13485:2016, IEC 62304/60601/82304.

This in-depth webinar will cover key aspects from these internationally recognized industry standards by explaining them in an easy to understand fashion.

Eliminate any previously held confusion and proceed with confidence with meeting the necessary requirements for your device.

SOME OF THE CHANGES WE WILL COVER INCLUDE:

Discuss what types of medical devices will require verification testing and how to identify what standards your device needs to test to.
Review best practices and common mistakes for IEC 60601 testing for electrical medical devices.
Provide details on the requirements for medical devices containing software and software as a medical device (SaMD) to show compliance to 62304/82304.
Discuss how to capture internal verification testing based on FDA guidance for test protocols and reports.
Review how using a design traceability matrix is essential to ensuring all of the required testing is completed.
Q&A session