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 [...]
30
10, 2024
24
10, 2024
5 Places to Use a FMEA in Your Quality Process
Before any road trip, it makes sense to check your tire pressure along with lev [...]
28
03, 2024
How EHS Software Solutions Can Revolutionize Workplace Safety
According to U.S. Bureau of Labor Statistics data, the number of preventable wor [...]
5
03, 2024
Top Considerations for Compliance Management Tools
Implementing an automated compliance management solution is a mammoth undertakin [...]
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 [...]
