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These are the Top 8 requirements for a Medical Device Manufacturing Engineer according to ChatGPT

It's essential to have a strong blend of education, experience, and skills to be successful in this highly regulated and technically...

Medical Device Process Validation: What are the REAL Odds of Passing?

Statistics tell us: (1) Passing a typical 3-lot PQ is not easy; (2) What to do about it. In medical device process validation (IQ OQ PQ)...

7 Process Validation Report Tips

These are the first 7 I would give someone drafting a process validation report (+PDF available with more tips!)

Root Cause Analysis: 3 Methods

An introduction to RCA, problem definition, and 3 common methods (+download PDF)

Medical Device Process Validation - Overview: Part 2

Continuation of Process Validation essentials discussion (+download PDF)

Medical Device Process Validation - Overview: Part 1

We begin our discussion of Process Validation essentials in Part 1 (+download PDF).

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