Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions
Course Director
Course Fee
$2150.00 Regular Registration
$1950.00 Early Bird Pricing (Register 30 Days in Advance)
Course Brochure
Future Live Stream Sessions (click to register)
Course Description
Geared for both experienced medical device professionals as well as those new to the industry, this 15 hour seminar is designed specifically for those who need a better understanding of the regulatory requirements necessary to bring medical devices to market in the US. This 510(k), PMAs and exemptions submission course discusses important regulatory requirements and concepts using case study discussions of real products from a variety of clinical specialties. Strategies for using regulation as a competitive advantage are also discussed.
All medical device pathways to market are presented with a discussion of the advantages and challenges of each. Multiple examples of products on the market, under development and on the drawing board (including videos) are presented in an interactive format. The seminar concludes with a look at the regulatory challenges for the future of the medical device industry including combination products, tissue engineering, and nanotechnology.
Using the case study, medical device submission course participants will learn to communicate more effectively with regulatory professionals and the FDA and understand how regulation impacts medical device development to get products to market quickly and efficiently and to avoid problems before they occur.
FAQs
Certification Tracks
Related Courses
- Design Control for Medical Device Professionals™
- Process Validation for Drugs and Biologics
- Preparation of FDA Submissions and Communicating with the FDA
- Medical Device Process Validation Training for Professionals
- Design Validation, Verification, and Risk Analysis for Medical Device Professionals
- Introduction to Medical Combination Products
Registrant Information:
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.