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Quality Management System for Medical Devices

Quality Management System for Medical Devices

Nonconformity Grading System for Regulatory Purposes and information Exchange This document is intended for regulatory authorities and auditing organizations. It introduces a standardized nonconformity grading system for regulatory purposes with a Regulatory Audit...

Audit Language Requirements

Audit Language Requirements

In preparing this guidance, the study group was not aware of any regulations, which required written translation of quality system documentation into a specific national language. However if this should be required it is recommended that this be limited to the very...

Global Guidance for Adverse Event Reporting for Medical Devices

Global Guidance for Adverse Event Reporting for Medical Devices

The objective of the adverse event reporting and subsequent evaluations is to improve protection of the health and safety of patients, users and others by disseminating information which may reduce the likelihood of, or prevent repetition of adverse events, or...

Regulatory Auditing Strategy

Regulatory Auditing Strategy

This document gives guidance to regulators and auditing organizations conducting audits of quality management systems of medical device manufacturers based on the process approach to quality management system requirements (e.g., ISO 13485:2003 and 21 CFR Part 820)....

Path to Creating a Distinct Competitive Advantage

Path to Creating a Distinct Competitive Advantage

Manufacturers need to take a much more demand-driven approach to integrating quality management and compliance throughout their organizations. Getting beyond the mindset that compliance to baseline requirement is “good enough” starts when quality management analytics...

How does FDA Train its Inspectors?

How does FDA Train its Inspectors?

Per US FDA, Corrective and Preventive Action is defined as a sub-system to collect information, analyze data, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to avoid recurrence. Verifying...

Best Practices and FDA QSR Mandate

Best Practices and FDA QSR Mandate

Establishing a corrective and preventive action (CAPA) system is a quality system requirement for Medical Device firms marketing products in the United States. Although the FDA has always expected regulated industries to perform corrective and preventive actions,...

ISO 9000:2008 Requirements

ISO 9000:2008 Requirements

Today’s competitive business environment has placed tremendous pressure on manufacturing companies to lower operating costs, address complex product design, outsource development and seek global expansion plans. Beyond this pressure there is major opportunity for...

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