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| With over 35 years’ experience in the medtech, diagnostics, and pharmaceutical markets, SMC Ltd. provides in-house engineering, injection molding, assembly, fill finish, device manufacturing, packaging services, and can manage sterilization. Our customers rely on us for speed-to-market and our program management process is a key to well managed projects. With inhouse global supply chain expertise, we help customers reduce risk while maintaining tight timeframes. Learn how we can excel your next project. |
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By Ulrich Lein and Stefani Godoy Herrera, MAIN5 | The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need. |
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| Cultural Audits: What Are They And Why Are They Essential? | Article | B. Braun OEM Division | The medical device industry is familiar with quality audits, but is less familiar with the benefits of having a cultural audit to assess the competence, dedication, and passion that each party brings to the table. |
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