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Medical Device Risk Management and ISO 14971

June 26th, 2014 by

ISO 14971[...] Read More

Dealing with FDA Warning Letters Before They Become a Problem

June 23rd, 2014 by

FDA Warning LettersMost life-sciences firms would agree that the best way to prepare for FDA Warning [...] Read More

Clarifying the Difference in Equipment Qualification and Process Validation

June 10th, 2014 by

Process ValidationHow do you know your life sciences firm is maintaining compliance? While FDA audits and [...] Read More

FMEA Methodology As It Relates To The FDA And Medical DevicesĀ 

June 6th, 2014 by

FMEA for Medical DevicesAlthough it was originally developed for high-risk military [...] Read More

Meeting Compliance Goals With Deviation Management And CAPA Systems

June 2nd, 2014 by

Deviation ManagementYour firm will experience compliance failures from time to time. In the realm of complex GxP-regulated [...] Read More