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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 

  • Revalidation.

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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.

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These are 12 tips I'd give to someone writing a process validation (PV) report: some of the exact things I look for when reviewing!

 

This checklist will help Medical Device professionals learn important content to include when writing PV reports, so they can get it right the first time and achieve faster approval times.

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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

  • Essential requirements

  • Design verification and design validation.

Other Tools

BOOKS: click on each title for link to the USA Amazon store

Note: I am not currently a member of Amazon's affiliate program.

Quality

  1. Out of the Crisis. W. Edwards Deming​

This is one of the most eye-opening books you can read about manufacturing, quality, statistics and how to perceive things in general. Central to the author's thesis is the fact that most failures (>80%) are failures due to the system - not to an individual person or circumstance. Highly recommended.

Career

THE definitive book on leadership. John C. Maxwell is the foremost authority on the subject and in this book he is at the top of his game. The audio book version - narrated by the author himself - is recommended.

Using a unique access code included with this book, you'll be able to take Gallup's StrengthsFinder assessment to discover your top 5 areas of natural ability.

  3.  Presentation Zen. Garr Reynolds

Do you wish you could make your presentations more engaging and effective? Garr Reynolds will teach you how: the key is simplicity...

Project Management

  1. The Mythical Man-Month. Frederick P. Brooks, Jr.

Don't let this book fool you. Although it was first written about software engineering in the '70s, the material is just as applicable to today's projects - a classic.

 

People in Product Development and R&D will be especially helped by the observations in this text: feature-itis, confusing effort with progress, and objective vs. subjective reality in new products.