3 easy steps to establishing a quality and regulatory strategy for your medical device (Scope phase)

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.

[MTB_Rider_]

Thanks you for that. However, I've had enough of the "Medical Device Theory" and the basics of the Med Device 101. After 25 years in the Medical Device industry and implementing and managing FDA 820 and ISO 13485 QMS's at several small, medium, and large Med Device companies world-wide, I'm only looking for some step-by-step instructions on how to actually use the software that my client has. What button to click on, where is that drop-down menu, how do I enter that piece of data, etc. I know what the software does and why - so, how does it work?

[alanlee]

Am I wrong that the speaker in the video is not looking directly into the video camera? I am just not used to the speaker not looking directly into the video, so it seems as if he is looking at someone else behind me. If he was talking to an interviewer then I am okay with him not looking directly into the camera.