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 [...]
In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rul [...]
Before any road trip, it makes sense to check your tire pressure along with lev [...]
In the highly regulated world of life sciences, data integrity is not optional [...]
How can a quality manager secure stakeholder engagement and hold individuals ac [...]
The challenge of the quality manager is to convince stakeholders of their respo [...]
Manufacturers widely view process improvement frameworks like Lean as the solut [...]
Manufacturers widely view process improvement frameworks like Lean as the solut [...]
As manufacturers face increased pressure to optimize their quality management pr [...]
With an unprecedented level of challenge and change in manufacturing, there is t [...]
There’s an old saying in regulated industries: if it isn’t documented, it didn’ [...]