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Medical Device Quality & Regulatory Consulting

Merging QA/RA Compliance with Operational Excellence

When people ask me why I've spent the last 23 years working in the Medical Device field, my answer is very simple...

 

"No one seeks medical treatment wanting to be harmed by the medical device that is supposed to treat them.  It's up to us, as people who design and manufacture the devices, to assure our products are safe and effective."

 

Robert Sestrick, President 

SERVICES

I am a consultant partnering with Medical Device manufacturers in the areas of:

 

Design Controls

Quality Engineering

Quality Management Systems

Regulatory Compliance

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ABOUT

My degree is in Electrical Engineering and I have held management positions in Engineering, Quality Assurance, and Quality Systems.  In each position I have held, one concept has always held true

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Right People + Right Process  = Quality & Compliance

 

CONTACT US

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