Blog

News

Medical Device Risk Management and ISO 14971

June 26th, 2014 by

ISO 14971ISO 14971 is one of the ISO standards that define the international requirements for medical device manufacturers by managing risk associated with the use of medical [...] 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 Letters is to take measures that prevent them from ever coming. Unfortunately, regulatory compliance is a complex beast, and it’s rarely possible to do everything perfectly.

Comprehensive compliance [...] 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 warning letters are obvious indicators, GMP guidelines give you a number of less-stressful ways to determine how well your equipment and processes are performing their tasks and whether they’ll continue to do so [...] 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 assessments, Failure Mode and Effects Analysis (FMEA) methodology has become essential for medical device manufacturers. Firms that want to market products intended for human use must provide some assurance that these [...] 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 processes, like automated pharmaceutical manufacturing and medical device quality assurance, things can go wrong with little advance warning.

While it would be nice to prevent such issues [...] Read More