Traceability Matrix Webinar for 510k Software Documentation

Wolfgang Huber is presenting a free Webinar on how to create a traceability matrix for 510k software documentation on Wednesday September 13th, 2017 10am – 11am (EDT).

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Providing a traceability matrix is one of the documentation requirements of the FDA for a 510k submission of medical devices containing software. Most companies use a spreadsheet to do this, but you deal with so many items that a traceabilty table would be huge. For the purpose of this webinar and our 510k workshop in Amsterdam, we can use a spreadsheet. However, when you have 100+ items in each category of your matrix, the matrix becomes quite unusable. Wolfgang will demonstrate how the same information you traditionally placed in a spreadsheet can be imported into a database for greater utility.

When is the Traceability Matrix Webinar by Wolfgang Huber?

This traceability matrix webinar will be presented live by Wolfgang Huber on Wednesday, September 13, 2017 10am – 11am (EDT). It’s free to register as long as you ask Wolfgang a question. As new questions are submitted I will create blogs to answer your questions and add the questions to our 510k FAQs page. In order to register for the traceability matrix webinar please fill in and submit the form below. You will receive an email confirmation including instructions on how to view and participate in the webinar via Zoom.

Contents of Traceability Matrix Webinar

Registrants will receive a confirmation email, and then after confirmation they will receive login information for the live traceability matrix webinar by Wolfgang Huber. We will also provide a link to download a recording of the webinar and the native slide deck. Additional questions can be asked at any time by sending me an email or scheduling a call on my contact us page.

About Your Traceability Matrix Webinar Instructor Wolfgang Huber

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Wolfgang Huber  is Co-Founder of Matrix Requirement Medical. He is a software engineer that will be speaking on IEC 62304 and the requirements for software documentation in a 510k submission. His company developed a web-based application to help medical devices organize documentation (requirements, specifications, use cases, tests, risk analysis) for their Design History File (DHF). The software eliminates the need to exchange word documents, maintains version control and automatically creates a traceability matrix. The company website includes testimonials for customers that use the software for creating their 510k submission documents.


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