Root-cause analysis (RCA) searches for the underlying cause of a problem instead of the symptoms. It's one of the first steps in implementing a solution that eliminates the causal chain of events that led to the problem.
Knowing RCA well, is one of the most important advantages someone could have in the Medical Device industry.
Learn the essentials of medical device process validation with these PDF slides, including:
Process verification v. validation
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Risk in validation
This overview is designed to give you a solid introduction to Medical Device Design Verification &Validation (DV&V).
You'll Learn About:
Intended use & user needs
Design inputs and output
Design verification and design validation.
“William is a diligent and highly capable engineer, well-versed in the world of medical device development and manufacturing. He is a dependable colleague and an excellent mentor.”
Thomas Newton, MS, PMP - Process Engineering Technical Leader
“William is a very experienced engineering professional and is very knowledgeable in complex manufacturing systems and quality systems. He has a strong work ethic and is dedicated to continuously leading product development projects, new technologies and contributing to the improvement of processes.”
Vanesa Fields - Medical Product Development Professional
“A man of high integrity, solid work ethic, and a willingness to share his knowledge.”
Brian Sherman - QA Device Specialist