Integrating design controls & risk management to streamline product development (Make phase)

Which QMS processes should be established during product development? We'll explain how design controls and risk management QMS processes should guide your product development and teach you ways to ensure the needs of your medical device are met.

This video covers the second step in our proven 5-step S.M.A.R.T methodology.

Using ISO 14971 best practices, you'll learn which risk-based processes you need to establish in your QMS at this stage of product development.

We'll go over four different quality processes that should be in place by the Make-phase of our S.M.A.R.T methodology:
1. Design Controls
2. Risk Management
3. Document Control and Records Management
4. Supplier Management

This video will cover why you should establish document control and records management as a way to properly document the objective evidence needed to support your design and risk controls. And if you plan to use any third-party suppliers, why implementing a process to manage these firms is a must.

You will also learn how to avoid costly mistakes made by manufacturers during this stage of setting up your QMS by reviewing common myths that exist and busting each one.

Follow these recommended QMS processes to streamline your product development efforts as you make your medical device.

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