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Medical Device Risk Management and ISO 14971

June 26th, 2014 by Zuhdi Hussein

ISO 14971 is one of the ISO standards that define the international. [...] Read More

Posted in medical device risk management

Dealing with FDA Warning Letters Before They Become a Problem

June 23rd, 2014 by Henry Macartney

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

Posted in production facilities

Clarifying the Difference in Equipment Qualification and Process Validation

June 10th, 2014 by James Francum

How do you know your life sciences firm is maintaining compliance? While FDA. [...] Read More

Posted in Quality Management System

FMEA Methodology As It Relates To The FDA And Medical Devices 

June 6th, 2014 by Zuhdi Hussein

Although it was originally developed for high-risk military assessments,. [...] Read More

Posted in Risk Management System

Meeting Compliance Goals With Deviation Management And CAPA Systems

June 2nd, 2014 by Henry Macartney

Your firm will experience compliance failures from time to time. In the realm. [...] Read More

Posted in Quality Management Systems

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