Navigating the US FDA for Combination Products

by Song Seto, Ph.D. | Jul 12, 2019 | Uncategorized

Our RA Manager Song Seto guides you through the FDAs pathway to get your combination product to the US market. Learn more about the combo products pre-market submission reviews and the other mechanism devised by the FDA and things that you should include in your pre-market submission.

Song Seto, Ph.D.

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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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Navigating the US FDA for Combination Products

Song Seto, Ph.D.

More Resources

Pattern Recognition as a Quality Superpower

Record Control for a Regulated World

EU MDR SSCP’s: The Importance of Readability

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