What Small Businesses Need to Know About ISO 13485 and the New FDA Rule for Medical Devices If you own a small business that makes or sells medical devices in the U.S., there is an important change in regulations. You should be aware of this change. The FDA is...
What is ISO 13485? ISO 13485 is a Quality Management System created for organizations involved in the design, production, installation, and servicing of medical devices and related services. The Impact of Covid on Medical Equipment Sales A few things happened related...
