All medical device manufacturers shall determine what needs to be validated and how much validation is enough to ensure regulatory requirements (i.e. FDA 21 CFR Part 820, ISO 13485) are met. If managed and implemented correctly, software validation provides significant business and regulatory benefits.
This presentation will be of interest to organizations which have to meet regulatory requirements for the validation of non-product software which includes off-the-shelf (OTS) software. The presentation will cover the challenges of software validation and highlight some cost-effective validation methods to help medical device companies to reduce the risk and cost of compliance.
Lecturers: MSc. Nadica Hrgarek
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