What does FDA require for Medical Devices Manufacturers to Do When Filing an Adverse Event Report (MDR)
As an experienced FDA medical device investigator, many firms have failed to fully incorporate the requirements of 21 CFR 803 when establishing and implementing their reporting procedures.
Speaker: Leo Lagrotte | View Anytime | Price: ¤189.00 | View Details
Medical Devices and Radiation-Emitting Products: FDA Requirements
As an experienced FDA medical device investigator, at one time or another many firms have failed to incorporate the requirements of 21 CFR 1002 and 21 CFR 1040 when designing and planning to file premarket clearance documents with FDA.
Speaker: Leo Lagrotte | View Anytime | Price: ¤189.00 | View Details
Complaint Handling for Medical Device Manufacturers
As an experienced FDA medical device investigator, approximately 90% of all FDA 483 I've issued contained inspectional observations that included firm's inability to establish and implement Complaint Handling procedures in compliance with 21 CFR 820, or failed to follow their own established procedures. Either way can get a firm into sufficient Warning Letter territory.
Speaker: Leo Lagrotte | View Anytime | Price: ¤189.00 | View Details