FDA Regulations for Medical Molding

Receive a 15% discount on Injection Molding Principles and Injection Molding Troubleshooting if registered for both workshops.

Course Date: 
Apr 18 2013 -
8:30am to 4:30pm
Melissa Maust
Course Outline: 

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.

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