How to validate an eQMS for Medical Devices? (ISO 13485 - FDA QSR)

► Webpage: podcast.easyme...
After eQMS implementation, we talk this week about eQMS validation and Jacob Sjorslev from SimplerQMS is really providing some great value by answering all the questions that a Medical Device Company should ask when having such software.
The validation of an electronic Quality Management System (eQMS) is not the same as for a product. There is a specific standard dedicated to this case and Jacob will help you understand it.
When you listen to Jacob you can feel that he is really passionate about what he is doing and the way he explain the different processes make real sense. I liked it when he said that a Medical Device manufacturer should not start with an eQMS but with paper. This is not something that you hear from another software developer.
► Who is Jacob Sjorslev
Jacob has been the VP of Business IT in a global medical devices company and started his career in business development and later became a project- and program manager.
Challenging local autonomy and willingness to change Jacob has been successful with a large portfolio of global digital transformation projects that have created common best of breed systems, best practice processes and a rock-solid method for implementing projects in the USA, Asia and the EU on time.
The results are optimized common processes, outsourcing of services, integrations with customers, external warehouses and suppliers and fast integration of acquired companies. The projects have contributed to growing the turnover with 250%, 650% on profit and 2500% on the share price.
The digital transformation experiences are now available for supporting Medical Device Startups with a cloud-based preconfigured and prevalidated eQMS system based on M-Files in Jacobs own company SimplerQMS.
► Link to the episode
■ Jacob Sjorslev LinkedIn: / jacobshyrdum
■ SimplerQms Website: www.simplerqms...
■ eQMS validation pdf to download: mailchi.mp/eas...
■ Episode 11 - Software Validation: podcast.easyme...
■ Episode 29 - 5 steps to create a Quality Management System: podcast.easyme...
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► Social Media to follow
■ Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#QualityManagementSystem #medicaldevice #ISO13485