Check with an issue or request a meeting which has a NAMSA pro to discuss your particular project. We're going to comply with up as swiftly as you possibly can. Also, you should explain to us how you heard about NAMSA.
Nearly all of my operate is in an authority witness role where by I operate carefully with attorneys to supply impartial views and recognize each the strengths and weaknesses of the customer’s situation.
With more than a decade of pioneering expertise in the regulatory consulting, DDReg stands out as being a trusted lover for medical device sector...
I have important encounter rescuing scientific trials and FDA submissions prone to failure due to compliance and articles issues.
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Dr. Guido Middeler Senior Specialist Enhancement and licensing Classification, CE marking, specialized documentation: We tend to be the qualified Get hold of for all aspects of regulatory and market place-similar concerns. Diapharm supports suppliers of medical devices, combination merchandise As well as in vitro diagnostics (IVDs) and tends to make their operate easier. a lot more >> Scientific evaluation All medical devices and in vitro diagnostics should undergo a medical analysis in accordance with the Medical Device Regulation (MDR) and In virto Diagnostics Regulation (IVDR). We have been here to aid! a lot more >> Conformity evaluation Medical devices As well as in vitro diagnostics (IVDs) are topic to A selection of varyingly elaborate conformity assessment techniques based upon their classification. They finish by using a declaration of conformity, a CE mark – plus the authorisation to bring the solution to current market. more >> Upkeep Diapharm ensures the monitoring and servicing of medical device As well as in vitro diagnostic conformity through the entire total product or service life cycle.
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I am an FDA regulatory professional witness and an FDA compliance consultant skilled during the polices and submissions of medicine, biologics and medical devices.
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Virtually all my perform is in an expert witness purpose exactly where I do the job medical device regulatory consultants carefully with attorneys to deliver unbiased opinions and discover each the strengths and weaknesses of the customer’s case.