Validation of Quality Software in Medical Devices

Have you ever been to an audit and the auditor asks you to show them the validation of your Quality Management System software? The first reflex is to say “But I buy it like that so I don’t validate that” and the auditor says, “Ok, then there is a non-conformity to ISO 13485”. I know painful. So let’s review today the way to validate your Quality tools and why this seems so important. For that, I have invited Christophe Girardey from Wega to answer my questions as he is helping companies validate their software.

Christophe Girardey is Managing Director at wega, a life science consulting company specialized in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, and configuring and validating the different Software tools to reach an optimal and qualitative Software Development. Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance.

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has…

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