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Supplier Qualification Process in Medical Device Manufacturing

by Syrma Johari MedTech | Nov 30, 2022 | Blog

A Medical Device is as good as its parts, this eventually makes supplier qualification process extremely important in Medical Device Design & Development. FDA 21 CFR 820.50 and ISO 13485:2016 Section 7.4 highlights major requirements for purchasing controls and...

Medical Device CAPA Process : Importance, benefits and implementation

by Syrma Johari MedTech | Nov 30, 2022 | Blog

A Medical Device Contract Manufacturing Organization is never at rest. With diversity of projects from different segments of Medical Device Industry, the possibilities of errors, risks, and upgrades are infinite. Every new project comes with its challenges and...

Medical Device Design and Development : The Ultimate Guide from scratch

by Syrma Johari MedTech | Dec 15, 2021 | Blog

Medical Device Design & Development is a multi-step process involving various resources and massive investments and long timelines. The process has sequential stages of ideation, designing, development, packaging, labeling, and delivery. Your Medical Device Design...

Medical Device OEM: Complete Guide to Manufacturers

by Syrma Johari MedTech | Dec 13, 2021 | Blog

The medical device industry is undergoing a dynamic shift and Medical Device OEM manufacturers are focused on bringing new technologies to the market. Medical Device OEM companies design, engineer, develop and deliver different types of medical devices. Some of the...
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