Risk Based MDLM™ Training for Medical Device Designers
Objectives
Training for the implementation of Risk Based MDLM™ in the design of medical devices.
Who Should Attend:
Designers involved in the design of medical devices.
Prerequisites
None.
Duration:
One day.
"Harpco Systems provides some of the most technologically advanced FMEA software tools on the market, buts its their disciplined technique that further separates them from all the rest. Harpco breaks down the barriers and corrects the pitfalls so companies can reap the full benefits of FMEA. Class room 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. Thanks Richard for opening our eyes and the FMEA Flip is awesome!"
Chris Follis, Regal Beloit Director of QualityI have been working with Harpco Systems for 20 yrs and have seen how their products and services continue to improve to meet customer demands. 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 QualityRich 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 infrastructure 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.
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.
Marv Beasley, Director of Engineering"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. Not only was the Harpco Systems process scrupulously meticulous in making us evaluate, question, define and then justify every single aspect of our product design, project risks and manufacture process, it was done at a pace that saved us months by not following our conventional processes. By cutting out all the waste and focusing our resources on what was truly important Harpco Systems enabled us to get to a state of production readiness months ahead of our projected schedule. This combined with the incredibly detailed, well documented and most importantly correctly linked/associated technical and risk file information prepared us with a watertight project file with no liabilities missed. Harpco Systems has changed the way myself and others approach product design and development for the better."