Are you ready to enter your medical device into the commercial marketplace? This course covers the specifics of regulatory submissions made to the FDA for the purpose of placing a medical device on the commercial market. Submissions covered will include: pre-submissions (pre-IDE and pre-510(k)); IDE; PMA; and 510(k). Additionally international submissions for CE mark will also be introduced.
This workshop style course will offer students an opportunity to practice understanding and gathering the complex scientific information required in various regulatory submissions. You will examine the process of writing medical device submissions for regulatory agencies, both nationally and internationally and will culminate with a preparation of a sample 510(k) submission.
- Laws and regulations of medical devices
- Device classifications
- Product development process
- Submission structure and content.
Practical Skill Development:
- Understand medical device product classifications
- Understand the premarket submission process, including 510(k), PMA and IDE
- Introduce students to the international submissions required to obtain CE mark for medical devices.
- Competently use the FDA website to find information for preparation of a FDA regulatory submission.
- Understand all the sections of a 510(k) submission and how to gather the information required
- Prepare a sample 510(k) submission for a medical device.
Overview of Regulatory Affairs for Medical Devices
Previous work experience
Course Number: BIOL-40325
Credit: 3.00 unit(s)
Related Certificate Programs: Regulatory Affairs for Medical Devices
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1/9/2023 - 3/20/2023
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Allison is a regulatory consultant focused on FDA submissions for the medical device industry. Throughout her career, she has been actively involved in hundreds of pre-submissions and premarket submissions for a wide array of medical device companies. Her previous company (AcKnowledge Regulatory Strategies, LLC) that she founded in 2014 was purchased by RQM+ in late 2021. At RQM+, she and her team continue to work with small to large medical device companies as they now support all device types during the entire product life cycle. Much of her recent work has been focused on digital therapeutics, monitoring devices, smart orthopedic devices, wearable technology, pediatric devices, and neurostimulators with unique indications. She frequently presents at conferences, is an advis...Read More
No information available at this time.
No refunds after: 1/16/2023.
1/9/2023 - 3/20/2023
You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
There are no sections of this course currently scheduled. Please contact the Science & Technology department at 858-534-3229 or email@example.com for information about when this course will be offered again.