R. M. Baldwin, Inc. has extensive industry experience in the biomedical engineering field designing innovative medical devices and systems for both hospital and field use.  Our experience includes the management and execution of projects from concept through production and distribution, and the development, implementation, and reporting of laboratory and clinical trials employing the technology developed.  It is our policy to maintain exact conformity with ISO and FDA requirements for pre-production quality control and design validation programs, ensuring a smooth path through regulatory and product approval processes in the United States and those of similar agencies around the world.

Services:

Contract Engineering:

 

We offer a full array of design engineering services with specialization in the development of new medical devices.  Projects may entail concept to completion management of a new product development program, or nearly any phase of the design cycle. Our Design & Development services include: mechanical and biomedical appliances, instrumentation systems, electronic devices, instrumentation to PC interfacing, and device prototyping and testing.

 

With our experience in the medical device field we are able to manage all aspects of the regulatory process during product development. This may include providing assistance with scientific studies related to the initial design concept to support required regulatory submissions, testing, and documentation. 

Prototyping:

 

We have in house capacity for the production of high precision mechanical, pneumatic, fluidic and electronic devices.  For larger needs, we maintain close working relationships with a number of complementary professional services ranging from machine shop and CAD support to industrial designers, programmers, and institution based research facilities.  Whether the object is to develop a single prototype to test a new idea or to launch a flagship product, we have the experience, and the resources, to get the job done.

Study Design / Grant Assistance:

 

The design of laboratory and clinical studies is a multi-disciplinary effort that requires the careful coordination of numerous activities.  Many companies cannot maintain all of the resources required to accomplish the difficult task of designing (and funding) meaningful and scientifically sound studies, studies that will support vital product approval studies and future marketing campaigns.  Our staff  has the experience to guide your organization through this process, and in so doing provides your staff with its own experience and expertise so that future efforts might be accomplished without outside help.