FDA Inspection Expectations in 2025
The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspect [...]
21
11, 2024
30
10, 2024
Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?
In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rul [...]
26
07, 2023
Risk Management in ISO 13485
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue i [...]
6
06, 2023
Linking Design Controls and Risk Management in the QMS
Design controls are a frequent citation in 483 observations and warning letters [...]
