In order to begin manufacturing and/or
distributing medical devices in the US or Europe, a company must first go
through a series of steps that are collectively referred to as registration.
The governing bodies in the United States and Europe require different
processes. QSOne, Inc. is able to assist you in the registration processes
of the United States and/or Europe regardless of your company’s location.
Within the United States, the process for the regulatory approval of medical devices is dependant on the
Class I devices are the least complicated and present the least risk.
The device cannot be not life-supporting or life-sustaining or for a use
which is of substantial importance in preventing impairment of human health,
and which does not present a potential unreasonable risk of illness of
injury. Class I devices are only subject to the FDA’s general controls.
General controls include an establishment’s FDA registration,
product listing, compliance with the FDA’s Quality System Regulations
and compliance with the FDA’s Medical Device Reporting regulations.
Class II devices are more complicated and present greater risks than
Class I devices. Class II devices are subject to the general controls listed
above as well as special controls that may include one or more of the
following: specific performance
standards, post market surveillance, and
pre-market notification requirements (510 (k)).
Class III devices present the greatest risk and are generally life supporting
or life sustaining, or for a use which is of substantial importance in
preventing impairment of human health, or if the device presents a potential
unreasonable risk of illness or injury. These devices are subject to all the
controls as a Class II device as well as an
IDE (Investigational device
exemption) and Pre-market Approval (PMA).