Aviation Parts to Medical Devices: Bridging the Gap
I.D. # C2101 Duration 7 Hours

This one-day program is designed to provide introductory information for those organizations who are considering transitioning from the Aeronautic, Space and Defense industry to the Food & Drug Administration (FDA), Medical Device Manufacturing market.

Reviewing essential information necessary to understand and successfully begin the journey to FDA Medical Device approval, this course will examine many of the controls between the AS9100 Standard and FDA Regulations and identify the similarities.
Learning Objectives
By attending this training program you will be able to:
  • Describe the medical device manufacturing landscape
  • Summarize the significant global players and identify their roles and responsibilities
  • Contrast the high-level FAA regulations and the FDA Medical Device regulations
  • Recognize device classification basics
  • Describe the steps involved to bring products to market
  • Discuss what to do next when transitioning
Who Should Attend
This training program is designed for quality and engineering professionals in the Aviation, Space and Defense industries who are interested in entering the FDA Medical Device Manufacturing Approval business sector.
Prerequisites

Prior knowledge and experience with the FAA Aircraft Certification Process and understanding the AS9100D and ISO 9001:2015 Quality Management System standard would be beneficial.


Seminar Content
Day One
  • Module 0:
    • Agenda and Introductions
  • Module 1:
    • Background, Landscape Change
    • Introduction to Regulation of Medical Devices
    • Key Players Involved Globally
    • Roles & Responsibilities
  • Module 2:
  • Comparative Difference Between FAA & FDA Regulations
Module 3:
  • Basics of Medical Device Classification
Module 4:
  • Steps for Bringing New Product to Market
  • Intro to Premarket Submission
  • Actions/Steps Moving Forward
  • Questions & Answers

Instructor(s): Paul J. Kunder

PaulMr. Kunder is the President of Amera-Veritas, Inc., a provider of quality, safety, and risk management services. Mr. Kunder is a lead instructor for the Aerospace Auditor Transition Training and is currently an International/Americas Quality Group and RABQSA AS9100 Aerospace Auditor and Quality System Lead Auditor. He is active in standards development as a voting member of the US Technical Advisory Group (TAG) to ISO Technical Committee 176 which is responsible for development of the ISO 9001 Standard. He serves as the Vice Chair of the National ANSI/ASQ Z1A Committee on Auditing (ISO 19011) and on the US TAG Interpretations Committee. He has performed more than five hundred audits and has assisted more than eighty organizations with the development and certification of their quality management systems including the Federal Aviation Administration Office of Aviation Safety. Prior to his current position, Mr. Kunder was involved in the accreditation of several 3rd party registrars, acted as an administrator for the first RAB accredited registrar in the United States and works as a subcontract auditor for a number of registrars. Mr. Kunder is an ASQ senior member and holds a B.S. in Mechanical Engineering.
Fees: $599 SAE Members: $539

 
CEU .7