Product Development and Engineering for Medical Devices (Level 4)
You are so close! The fourth and final portion of this path will explore more advanced topics like usability, agile design and development, and application of design principles.
Who Owns Risk Management and How Does it Impact the Business?
A session by Jon Speer, Founder at Greenlight Guru
1 hr 1 min
Show Overview
What is the Best Way to Structure a Risk Management File
A session by Carolyn Guthrie, Director QA/RA at Kapstone Medical
0 hr 48 min
Show Overview
Ultimate guide to Agile Design and Development for Medical Devices
In this guide, we discuss how the Agile Method for Medical Device Design is an iterative process that includes all products and product features that are tested, verified and validated, and allows for tweaks, requirement changes, risk updates and compliance updates as needed.
Show Overview
The Intersection of Medical Device Usability and Risk Management
Mike Drues joins the podcast again to talk some more about Risk Management
Show Overview
The Definitive Guide to Change Management for Medical Devices
This guide will detail the change management best practices that medical device companies need to understand and follow when making changes to documents, products, processes, and more.
Show Overview
Risks that No One Wants to Talk About: Theoretical Risk Management vs. Life in the Real World
A session by Mike Drues Ph.D., President at Vascular Sciences
0 hr 55 min
Show Overview
Risk Management for Executives: Why Does it Matter to Me?
A session by Michael Cremeans, Life Sciences Industry Practice Leader at Hylant
0 hr 44 min
Show Overview
Implementing and Maintaining Changes to SaMD Under MDR
This session will cover the outline of MDR requirements for SaMD, including qualification and classification, clinical evaluation and expanded post-market activities among others.
0 hr 51 min
Show Overview
Risk Management from a Regulatory and Product Development Perspective
Another favorite podcast episode with our frequent guest Mike Drues, Ph.D.
Show Overview
Product Development and Engineering Checkpoint Delta
What an accomplishment! You spent the time, invested in your own knowledge, and now it's time to celebrate. Now hop in here and get your Guru Badge, so you can show off a little.
Show Overview
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