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.