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China UDI Requirements

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Unique device identifier refers to a series of codes constituted of numbers, letters and/or symbols and established on the basis of standards. Unique device identifier, which includes product iden…
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Regulatory Success Automation

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You may think that regulatory automation is something that requires an intense technical infrastructure backed by a big budget to boot. But the truth is, even small businesses can use simple autom…
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Medical Devices: Structured Content Authoring Saves Time & Reduces Cost

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Medical device companies creating technical documentation, clinical / post-marketing reports, labeling and quality documentation with increasing regulations and recent MDR/IVDR compliance in mind …
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Avoiding Regulatory shortfalls in the Submission Path

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Commercialization of new drugsrequire careful navigation through complex regulations defined by Global health authorities. Drug development process needs extensive collaborations with internal &am…
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Med Writing: 4 Best Practices for Reusable Global Content

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In order to scale, you must reuse content; To reuse content, you must standardize content; To create standardized content, you must develop standards that all content creators adhere to Why Bes…
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