Founded in 1987, Harpco Systems specializes in providing software, training and consulting for managing a product during its entire life cycle. Over the past 33 years Harpco Systems has helped hundreds of companies implement improved design and manufacturing systems in a wide variety of industries. The implemented systems are compliant with ISO 9001:2015, ISO 13485:2016, IATF 16959:2016 and AS 9100:2016. Harpco Systems is a recognized leader in the implementation of "Risk-based Thinking". Its founder, Richard Harpster, has published multiple papers, provided webinars and spoke at multiple national and international conferences on the implementation of Risk Based Thinking to improve a company's profitability and meet current QMS standards such as ISO 9001:2015 and ISO 13485:2016. Harpco Systems has developed Risked Based Product Lifecycle Management (aka Risk Based PLM) to manage risk from the definition of customer requirements through to the use and disposal of the product. Realizing that the Medical Device industry has special needs, the company has also developed a Medical Device specific risk based product life cycle management system called Risk Based Medical Device Lifecycle Management (aka Risk Based MDLM) . The Risk Based MDLM system consulting, training and software teaches Medical Device companies how to combine the best practices of the Medical Device industry and other industries such as Automotive and Aerospace to dramatically improve their design and manufacturing systems. Harpco Systems is a recognized expert in the application of FMEAs and has invented several new concepts including the linking of Design FMEAs to Process FMEAs in 1990 which became an automotive industry standard eighteen years later. The companies latest inventions in the field of Risk Based PLM and Risk Based MDLM include Requirements Risk Assessment (RRA), Multiple Integrated Cause Analysis (MICA) and Rapid Integrated Problem Solving (RIPS).