EMMA International’s Body of Knowledge (BOK)

by Emma International | Jan 26, 2022 | 510k, AI, biologics, CAPA, Combination Products, Cosmetics, COVID-19, Digital Health, Enforcement Actions, EU MDR, FDA, Gene and Cell Therapies, Medical Devices, MedTech, Pharmaceuticals, Post-Market, Product Development, QMS, Quality, Regulatory

Do you enjoy all the content from EMMA International? We have good news for you!

We are proud to announce that our inaugural annual e-book, the EMMA International’s Body of Knowledge (EMMA BOK^TM), is here! The EMMA BOK^TM is a complete compilation of our 2021 content, including: our Blogs, Whitepapers, Webinars, and featuring Industry Trends

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Pattern Recognition as a Quality Superpower

There are always new ways and reasons to apply pattern recognition to quality improvement. Better ensuring patient outcomes in health care facilities and improving accuracy for medical diagnoses are two such frontiers.

Record Control for a Regulated World

In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”

EU MDR SSCP’s: The Importance of Readability

Among many of the new requirements that EU MDR has introduced, the Summary of Safety and Clinical Performance (SSCP) is certainly one of the more confusing ones for many firms. SSCP’s are required for implantable and Class III devices under EU MDR and is intended to be a public document summarizing important safety and clinical performance information about the device.

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