3 easy steps to establishing a quality and regulatory strategy for your medical device (Scope phase)
Автор: Greenlight Guru
Загружено: 2020-01-30
Просмотров: 3647
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How do I know which regulations apply to my medical device? What should I include in my quality plan to ensure ongoing compliance and success of my medical device? We’ll show you how to establish a solid quality plan and regulatory strategy that will guide your quality management system (QMS) processes throughout the total life cycle of your medical device.
This video covers the Scope phase of our proven 5-step S.M.A.R.T QMS implementation methodology, which will help you through the important steps necessary for creating your quality and regulatory plan.
We’ll share proven best practices and tips to help you determine your product classification, allowing you to better gauge the costs associated with marketing your medical device. And in doing so, this will help give you a general idea of the scope of your overall project.
Your device classification will dictate how you draft your regulatory strategy and quality plan. Your plan will guide your product development efforts and well beyond into your postmarket activities.
SUBSCRIBE to our channel for creating a quick and easy quality plan and regulatory strategy for your QMS! https://www.youtube.com/c/greenlightg...
Looking to accelerate your device's timeline to market and keep it there? Learn how our Medical Device QMS software can help: https://www.greenlight.guru/quality-m...
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