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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 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...

Software development in Medical Device Manufacturing: Coping with SCAM (Social, Cloud, Analytics and Mobility areas)

by Syrma Johari MedTech | Dec 6, 2021 | Blog

During the COVID-19 lockdowns, the necessity for remote health consultation and checkups led to the significant rise of the healthcare segment called “Telehealth” offering accessible healthcare within the comfort of the user’s home. Incorporating AI, ML along...
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Recent Posts

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  • In Vitro Diagnostics (IVD) Growth & Trends: Clinical Impact Meets Commercial Opportunity
  • Syrma Johari MedTech at The MedTech Conference 2025: Connecting with Global MedTech Leaders
  • Strengthening Supplier Assessment in Medical Devices: Best Practices for Quality, Compliance, and Risk Mitigation
  • Global Regulatory Submissions for Medical Devices
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