Application FMEA For Medical Devices 2017-03-02T10:35:52+00:00

Effective Application FMEA For Medical Devices Implementation And Use

(Note: Training offered in both class and workshop format)


  1. (Class, Workshop)

    Give attendees an in depth knowledge of how to use the Application FMEA (also known as an Usage FMEA) to identify the risks created by improper use of a medical device and how to define the proper controls to reduce the risk.

  2. (Workshop)

    Make significant progress if not complete the development of Application FMEA and Control Plan for a product of the class’s choice.

Who Should Attend

  1. All personnel who are responsible for the creation of instructions on how to properly store, transport and use the medical device.

Rich was asked to help us put together a Design Control and Risk Management program for our Immunodiagnostics products. Rich worked with us to build the necessary infrustructure to make the system comprehensive for the level of complexity needed to handle our products. During this time, Rich was not only helpful in putting the system in place, but also educating us on the thought process to evaluate product design and process control. In doing so, Rich provided us with the fundamental concepts to be able to decompose any product or process problem to arrive at an effective solution. He has left a lasting impression on our organization.
Scott Richards, Manager, Risk Management at Abbott Diagnostics


  1. Students must have knowledge of the medical device and its proper use that they choose to use in the class exercises.


  1. Class Duration: 1 Day;
  2. Workshop Duration: 3-4 days, depending on application served.


  1. What is an Application FMEA
  2. Why perform an Application FMEA
  3. When to perform an Application FMEA
  4. Who should participate in the Application FMEA process
  5. How to conduct an Application FMEA:
    1. How to create a Process Path for the Application FMEA;
    2. Two types of Application FMEA Failure Modes;
    3. Defining Failure Mode Effects;
    4. How to determine Severity (SEV) ratings in two minutes or less;
    5. Creation of the Application Specification Analysis;
    6. Nine sources of application failure;
    7. How to determine Occurrence (OCC) ratings in 15 seconds or less;
    8. The difference between prevention and detection controls;
    9. How to calculate the Risk Priority Number (RPN) and why it should be rarely used to determine what to work on;
    10. How to determine Class designations in the Application FMEA and their importance in determining what must be worked on.
  6. Medical Device Type:
    1. Implantable:

      Step by step method for performing Application FMEA for an implantable medical device including tools used for implantation and implant site preparation;

    2. Non-Implantable:

      Step by step method for performing Application FMEA for a non-implantable medical device

  7. How to Construct an Application Control Plan.
Want to schedule this class? Call us today at (248) 374-1718 or fill out the form for more info.


“Harpco breaks down the barriers and corrects the pitfalls so companies can reap the full benefits of FMEA. Classroom training not only properly teaches FMEA, but participants actually build their business’s FMEA as they go and are often blown away by how much work got accomplished. Harpco Systems has become known as the Modern FMEA for a reason. Its structured, simplified and sustainable.”
Chris Follis, Regal Beloit Director of Quality
“Harpco’s training is first rate and helps develop new ways of thinking about the importance of creating proper specifications early. Separately, I’ve seen firsthand the effectiveness of using their approach in problem solving, helping to advance problems that had reached a stall using traditional methods.”
Todd Gross, VP of Global Quality
“I would like to thank Harpco Systems for the help, advice and frankly the education in how to design, develop, source and manufacture new to world products.”
Jonathan Flood, Engineering Manager
“We were very fortunate to work with Rich Harpster and his team as we improved our DFMEA process at Calsonic. There is no better teacher, coach, implementer than Rich when it comes to creating a knowledge base for engineers to use in creating part specs to assure that products meet the customer’s requirements. Rich teaches the basics, then he accelerates the FMEA process so that requirements and specs are related in a database that can be continually updated.”
Marv Beasley, Director of Engineering