Event Details
8 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities and on-site at your organization
This course is designed for individuals involved with medical device development, as well as those who would like to learn about the FDA regulatory approval process for medical devices.
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Please contact us if you are interested in private training for this workshop.
8 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities and on-site at your organization
Food and Drug Administration (FDA) 510(k) clearance is a requirement to market medical device products in the United States. Consequently, medical device companies must determine the best regulatory path to bring their products to market, as well as what is needed to complete the 510(k) process, and when a 510(k) must be submitted.
This course provides participants with an overview of the FDA regulatory approval process, with a focus on avoiding regulatory issues and unnecessary expenses. Participants will also learn how to submit a successful Premarket Notification 510(k) Submission for a device or a device change as quickly and efficiently as possible and ensure a 510(k) submission can be quickly reviewed and cleared by the FDA in order to stay ahead of the competition.
This course is designed for individuals involved with medical device development, as well as those who would like to learn about the FDA regulatory approval process for medical devices.
Upon completion of this course, participants will have a solid understanding of the FDA regulatory approval process for medical devices, including the Premarket Notification 510(k) Submission Process, as well as Labeling, Marketing, and Post-market Responsibilities.
Chris, Angelo and Barbara,
The recent meeting “What we can learn from FDA Warning Letter” was an excellent and exactly what I was looking for. Please keep me on the list for future meetings. Real professional of you folks. I have given your companies information out to an acquaintance from ASQ as a source for training for internal auditing. Looking forward to a long relationship with your team.
Hi Angelo,
Great ISO 13485:2016 Internal Auditing class, honestly the most well run and informative class I’ve taken.
Hi Angelo,
We are satisfied with the process and the report. Gordon does a good job! He is up on the regulations and what we need to focus on. I have found in past years what he points out is what comes up on the radar with the Notified Body. It helps us to be ready for the process.
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