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About
Us
We
are a truly unique consulting firm offering a comprehensive approach to product
development, regulatory compliance, and engineering. Established
in 1995, R. M. Baldwin is a
Michigan
based company dedicated to bringing excellence to the
development of new medical technologies and bringing world class quality and
value to our clients.
Our professional staff with over 40 years combined experience
in the medical device field is organized to provide a perfect blend of product
design, project management, training, and engineering support while satisfying
all regulatory requirements throughout the process.
With
particular Biomedical Engineering expertise in the fields of cardiac and
respiratory care, lung simulation and cardiopulmonary resuscitation, our
services encompass system specification, mechanical,
electronic and biomedical design, software design and development, product
prototyping, clinical investigation and regulatory affairs. From concept
to production, we maintain strict conformity with ISO and FDA requirements for
pre-production quality control and design validation programs, ensuring a
smooth path through the regulatory and product approval processes in the
US
and those of counterpart agencies throughout the world.
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Our Promise
To help
you produce excellent products,
products you are proud to offer, because we take pride in the work
we do for you. Our engineering and regulatory programs and services
are all designed to enhance your products, and our success depends on doing
that for you. Our goal is to save you
time, which will save
you money, which will bring you
peace of mind.
We strive to provide you
with timely and tangible results
that exceed your expectations, shorten the product design cycle, and positively
impact your bottom line.
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