How do I know which regulations apply to my medical device? What should I include in my quality plan to ensure continued compliance and success of my medical device? We'll show you how to create a solid quality plan and regulatory strategy that will guide your quality management system (QMS) processes throughout the entire lifecycle of your medical device.

This video covers the Scope phase of our proven 5-step SMART QMS implementation methodology, which will guide you through the important steps required to create your quality and regulatory plan.

We share proven best practices and tips to help you determine your product classification so you can better estimate the costs associated with bringing your medical device to market. And by doing this, you will get a general idea of the scope of your overall project.

Your device classification determines how you build your regulatory strategy and quality plan. Your plan will guide your product development efforts and well beyond into your post-market activities.

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Want to speed up your device's timeline to get to market and keep it there? Find out how our medical device QMS software can help you: https://www.greenlight.guru/quality-management-software

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