SMART quality & compliance
Risk-Based Computerized System Validation (CSV) and Computer Software Assurance (CSA) – Old Wine in a New Bottle?
“Discovering the unexpected is more important than confirming the known.” —George Box, Stuart Hunter, and William G. Hunter Introduction The World Health Organisation (WHO) specifies that “the purpose of validation is to confirm that the computerized system specifications conform to the user’s needs and intended use by examination and provision of documented and objective evidence that the particular requirements can be fulfilled consistently.” Validation should establish confidence in the accuracy, reliability and consistency in the performance of the system and it should also ensure that all necessary technical and procedural controls are implemented confirming compliance with good documentation practices for…
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SMART quality & compliance, Uncategorized
What is the development lifecycle of a Medical Device?
What is the development lifecycle of a Medical Device? First and foremost, the user requirements need to be defined by the organization. Based on the fact that the design and development of the Medical Device can be planned, inputs are implemented and tested, which lead to outputs. The design and development process is then verified, and if needed, some inputs can be added (related to the outputs). The whole process is validated; the CE marking must be accepted before transferring the design and development to production and commercialization. The entire lifecycle is continually controlled. Risk management must be included in…
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