Mr. Patel has over 25 years of experience in quality assurance and regulatory affairs, with the past 12 years spent at the FDA.
Global Leader
What to Do When Regulations Do Not Work (for You)
Some of the most challenging situations I have had to confront during my career have involved achieving compliance with regulations.
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.
Key Performance Indicators Unlock Potential
There are right and wrong approaches for using measures to achieve performance improvement. Knowing the difference requires some book-learning, but mostly the wisdom of broad and deep experience.
Before you “Pull the Plug” on a struggling project-Call EMMA International
There can be a multitude of reasons why troubled projects are delayed in being abandoned or brought under...
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