We work with many groups that develop medical devices; they can be grouped into these categories:
We work with Social Entrepreneurs whose projects can be considered medical devices aimed at low-resource settings or otherwise fill an unmet need in a neglected population. Devices like these are sometimes referred to as "appropriate technology."
Student groups usually fall into this category, as well as several professional groups and individuals.
These Quality System elements are especially important for Designers:
These Quality System elements are especially important for Contract Manufacturers:
These Quality System elements are especially important for Distributors:
All elements of a robust Quality System are necessary for an OEM.
When you turn to commercialization, you need to keep a careful eye on the quality of your products - and the organization itself!
We develop Quality Systems that are aligned with the GHTF and with requirements of the FDA, ISO, and other global regulations as applicable for the target market. Of course, there is no one-size-fits-all quality system. We work closely with our clients to develop the system correct for them, with all the particulars of the regulatory environment appropriate for their product and market.