Sponsored Webcast: Mastering your 510(k) submission process (On Demand) (Oct 2023)
Bringing a Class II medical device to the American market? You’ll need to go through the 510(k) process, your gateway to FDA clearance. Yet many businesses are getting it wrong: successful applications are falling, and 30% of 2021 applications weren’t even accepted for initial review.
A robust 510(k) plan is crucial for a smooth and speedy route to market. This webinar gives you everything you need to know to become a 510(k) master.
Registration Fees & Deadlines
Free
Learning Objectives
After this program, participants will be able to:
- Understand the optimal pathway to follow for right-first-time, stress-free 510(k) clearance
- Learn the most common mistakes the FDA sees in applications, and how to avoid them
- Unpick the key ingredients of a 510(k) submission, from predicate devices and substantial equivalence to typical timelines
Who Should Attend?
- Quality Assurance
- Quality Managers
- Regulatory Managers
- Quality Directors
Audience Learning Level:
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Speaker:
Sumatha Kondabolu
Quali, Senior Quality Specialist
Jerry Adatsi
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
