Honorees are role models for success in business and commerce
ISO vs. FDA audits, Baldrige winners, and what we can learn from GE
How BioBridge Global leverages a digital QMS in the heavily regulated world of regenerative medicines
From digital submissions to integrated document control, the agency moves into the lean arena
By scaring off small medical-device companies, Canada could limit number of important and innovative products
For answers to some troubling life-science questions, ask a quality professional
Finch Therapeutics forges a QMS for a life-saving treatment not yet approved by the FDA
Compliance, quality, and serving the patient
The standard is synergistic with OSHA requirements, including the Voluntary Protection Program
ISO 45001 marks a significant step in the overall effort to improve OH&S standards worldwide
Procedure doesn’t allow nonconforming units in the sample, has superior detection capabilities
In the politically correct world of PPM defective, MIL-STD-105 is a misunderstood and misapplied specification
Thirty years of selected supplier-development case studies from Omnex
We keep trying to find the needle in a haystack
Welcome home!
Regulatory work must keep pace with emerging cancer therapies
Why you should start employing a risk-based mindset
Properly identifying uncertainties is key to mitigating risk
Teams must be able to access, collaborate, update, and test each requirement through to project completion
If something can be stressed, its reference standard stability must be considered