FDA Regulations for Medical Molding
Fee: $700
Instructor: Melissa Maust
Description
The presentation will provide a basic understanding of the connection between injection molding and the regulatory environment for the medical device industry. Development of regulatory strategy through documented quality systems provides the necessary controls for process design, product development and quality which are critical to effective implementation, consistency and reliability throughout all stages of the product's life. Maintaining regulatory compliance reflects product safety and quality, and ultimately customer satisfaction.
General Outline
Session 1: Overview of Regulatory Systems (21 CRF Part 820/ISO 13485)
Session 2: Applicability of Regulatory Systems for Injection Molders
Session 3: How to Establish and Implement a Regulatory System
Session 4: How to Maintain a Regulatory System