Understanding the FDA's regulatory system is the first objective for device manufacturers looking to sell in the U.S. The 510(k) Premarket Notification submission should be prioritized when developing a medical device. This pathway provides marketing clearance and the ability to sell your medical devices in the U.S. Before sales can occur companies have two options: 510(k) Premarket Notification (unless exempt); or Premarket Approval (PMA) approval. PMA’s are resource intensive, and so 510(k)’s are the ideal submission type.
Areas Covered in the seminar:
Who will benefit:
QUALITY REMEDY provides regulatory support, quality management consulting, and product development solutions to medical device companies. As a regulated industry, medical device development is a complex world. This sector requires strict processes, robust records, internal/external auditing and much more in order to demonstrate product safety and effectiveness. Let us help you abide by the constantly evolving guidelines.