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FMEA Methodology As It Relates To The FDA And Medical Devices 

June 6th, 2014 by

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

Improving CAPA in the Regulated Industries

May 29th, 2014 by

CAPA SystemCorrective and preventive actions, or CAPAs, play a vital role in how GxP firms maintain compliance with FDA standards. A corrective action (CA) is an action to [...] Read More

Quality Management Steps of Risk Assessment

May 22nd, 2014 by

CAPA Risk ManagementQuality risk management implementation identifies and manages risks; under normal circumstances the [...] Read More

Can Medical Device Compliance Consulting Benefit You?

April 29th, 2014 by

Compliance ConsultingAs all medical device manufacturers know, life sciences firms are bound by GxP rules and recommendations. Firms [...] Read More

Understanding The CAPA Process During FDA Medical Device Compliance Inspections

April 14th, 2014 by

CAPA Inspection[...] Read More

Demystifying FDA Corrective and Preventive Actions

February 6th, 2014 by

Corrective and Preventive ActionsRegulations outlined in FDA CFR 21 state that manufacturers must implement and maintain processes for corrective and preventive actions. Also known as CAPA systems, the implementations that deal with [...] Read More