About: Jon Speer
Jon Speer has been in the medical device industry for over 16 years. In 2007, Jon started Creo Quality to help medical device companies with project management, quality systems, and regulatory submissions. As a result of his experience in the medical device industry, Jon had an idea to develop a software solution to improve how companies handles Design Controls. Because of this greenlight.guru was born. You can find him on Google+, Twitter, and LinkedIn.
Recent Posts by Jon Speer
Move to ISO 14971 Risk ManagementISO 14971 provides a very clear definition of risk: RISK - combination of the probability of occurrence of harm and the severity of that harm No mention of detectability or detection. ISO 14971 has been in existence for many, many years. The 2007 version has been harmonized for quite some time. This means that ISO 14971 is the medical device industry's go to standard for medical device risk management. Bottom line: Your risk management process must conform to ISO 14971. It is also possible that you might be clinging to the value of detectability...
Risk Management - systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring riskAnd to be fair, I'll also share with you a definition / description of FMEA from ASQ
Failure Modes and Effects Analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service.
Journey into Design ControlsAs I mentioned, the company already had an existing double-lumen introducer on the market. However, the product had a few issues and was not...
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