Compliance4All, Online
2017-01-25
Overview: The majority of medical devices are cleared for marketing in the U.S. by
the FDA under the 510(k) process. The FDA holds companies responsible
for filing new 510(k)s when one change is major enough to impact
safety / effectiveness, or when a series of lesser changes finally reach
the "tipping point".
Areas Covered in the Session: U.S. FDA device clearance / approval FDA's and EU's emphasis Product changes and filing a new 510(k) - who's responsible Tracking and evaluating changes - the "tipping point"
Who Will Benefit: Senior management, project leaders, internal / external consultants Regulatory affairs Quality systems personnel / QAE R&D and engineering staff
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