INDIANA MEDICAL DEVICE MANUFACTURERS COUNCIL
IMDMC 2014 FDA Regulatory 101 Course
This popular annual education offering is for employees relatively new to the FDA regulatory world or who need a FDA refresher. It is an inexpensive course that utilizes several of our state’s medical device FDA regulatory experts. These presenters are experienced industry regulatory champions who give a “soup to nuts” overview of FDA medical device regulation. The faculty incorporates peer-learning activities with their presentations.
Day One of Reg 101 occurred on May 15; Day Two is on August 19th. It is not necessary to have completed Day One to attend and benefit from Day Two.
Day Two’s agenda will include: overview of post-market requirements; quality system regulation; advertising and promotion; MDR reporting; recalls; inspections; and enforcement. An official from the FDA Detroit District Office will be joining the day's faculty.
The comments from Day One’s attendees were very positive about the splitting of the course into two days, the instructors, and the appropriate depth of information. Plus, everyone loves the food at the Montage!
Continuing Legal Education Credits: We will apply 7 CLE hours.
Fees for Day Two are $195 for IMDMC members and $275 for non-members. For members, after the first four registrations from the same company, there will be a $45 discount for each subsequent registration. If using this discount, please contact imdmc@imdmc.org.