Multi-interfaces Entity Model for Summative Risk Management of Medical Products

Currently, product development of highly regulated products is usually aided by modern PLM systems as an information backbone that reflect and support various business processes. Changes are systematically handled and the overall impact is made transparent through configuration management. In the search to maintain the integrity of all systems and components over the span of the product's life, a tightly integrated Risk Management process and system shall enable a discrete but frequent enough method. The goal is to evaluate if further product development or changes are needed. Also clearly give quantifiable values to assess if the next step in the product's lifecycle can be started and closed. The challenge is finding a methodology where risk management is living process throughout the lifecycle, which is cumulative, so the risk assessments refine with the product's definition. It should be enabled to be done at the component level so risks add up modularly to the complete product's risk assessment. This process should be embedded in the PLM processes so it is able to accompany the product throughout its life. We investigated the usage of the Multi-interfaces Entity Model (MIEM) integrated with a summative risk management concept that allows an incremental risk analysis, as the entities in the MIEM are refined. The results were a recursive methodology that supported with a PLM integrated risk management, can be automated to make sure the risk assessment is complete, re-usable and configurable. The next steps are the implementation in this concept with the PLM architecture and make it possible to support further views of the products for the nest lifecycles. With this approach the intention is to avoid having a very heavy risk management at the definition and design phase that is later left to a lower plane in the life of the product.