Upon completion of this course, participants should be able to:
- Understand and reference the QSR in terms
of the requirements for a medical device manufacturer when designing,
manufacturing, packaging and distributing medical devices, as well as
the applicable post distribution functions.
- Understand the QSR requirements for a Quality
Management System (QMS) in order to advise a medical device
manufacturer about the establishment, implementation, and maintenance of
an effective QMS.
- Apply the requirements mandated by FDA for
medical device manufacturers to the different processes within the
organization, including those events that occur post distribution to
market, such as installation, servicing or customer complaint handling.
- Identify the different procedures, work processes and quality
records that must be generated to support FDA compliance to the QSR.