Medical Plastics

Medical device manufacturers (OEM) are looking closely at the quality and value provided by suppliers contracted for injection molded product, services and system assemblies.

This 3-day seminar was developed to educate both OEM companies (customer) and molding companies (supplier) on what key processes are required to create a winning team relationship between the two groups.  The course covers an overview of the regulatory requirements for manufacture of medical devices, reference FDA and ISO 13485 standards, and includes information on the steps involved to become ISO certified.  Course material includes a review of documentation requirements for part and mold design, including instruction on mold/process validation.  Record control requirements for injection molding are covered, with emphasis on critical areas of the Quality Management System.  This includes review of the Device Master Record, product acceptance, calibration, employee training, material traceability and product non-conformance.

Completion of the course gives both OEM companies and their injection molding suppliers detailed methods to compete at a higher level by implementing process systems that will improve product quality and company performance.

Course Dates


Course Outline

  1. Medical Device Regulatory Requirements
    1. FDA 21 CFR Part 820 and ISO 13485
    2. The Quality Management System
    3. Process Approach
    4. Why ISO and Process for ISO 13485 Certification
  2. DHF (Design History File) Requirements
    1. Part Design Documentation
    2. Mold Design Documentation
    3. Risk Management for Design and Process
    4. Device Master Record for molders
  3. Injection Mold and Process Qualification
    1. Requirements for IQ, OQ and PQ
    2. Approach for managing the process (work templates provided)
  4. Procedures and Records for Molders
    1. Product Specifications
    2. Process Documentation (Device History Record)
    3. Product Acceptance
  5. Quality System Requirements
    1. Employee Training
    2. Equipment and measurement Calibration
    3. Material Traceability
    4. Product Non-Conformance


Additional Information

  • Course duration is three (3) days
  • Price: $1,475 USD
  • Courses are held 1524 East 10th Street, Erie, PA 16511
  • Participants receive a course manual