Risk-Based Thinking in ISO 13485 (and How It’s Different from ISO 9001)
Risk-based thinking is one of those phrases that is mentioned frequently within ISO management system…
ISO 13485: QMS Requirements of Medical Devices for Regulatory Purposes
By IJ Arora, Ph.D. ISO 13485:2016 is a standard that addresses quality management system…
Profile: Ralph Hiltebrand
Ralph Hiltebrand is the principal and co-founder of GHR Associates. He has more than 20…
New Handbook Helps Medical Devices Sector Improve Quality Management Systems
by Sandrine Tranchard The medical devices industry is one of the most highly regulated sectors in…
Workshop to Address Medical Device Regulatory Changes
TÜV SÜD will host a workshop in March to help manufacturers understand the changing medical…
ANAB Joins IAAC MLA for Medical Devices
ANAB has been approved as a member of the InterAmerican Accreditation Cooperation (IAAC) multilateral recognition…
Which Medical Device Quality System Is Right for You?
by William I. White In structuring quality management systems, most medical device companies choose a…