Preparation for Preapproval Inspections

A Premarket Approval Application for a Class III medical device begins a cascade of activities that requires a company to be operating at peak performance as your product design, product manufacturing and quality system will be under intense scrutiny. Preparing for a Premarket Approval (PMA) inspection will protect the investment your company has made in developing a Class III device and improve the likelihood of product approval.

Establishing a PMA inspection preparation program during the development of your Class III product makes compliance integral to the company’s success and gives your new product a greater chance of a favorable inspection outcome. From this webcast, you will learn how to frame a program to prepare your organization for the rigors of a PMA inspection. You will see a framework of the program, compliance analysis and process interfaces to identify areas of potential noncompliance risks that can impact product approval. This program model is also applicable to Class I and Class II products.