Risk Management

AssurX’s “Risk Management” articles provide valuable insights into integrating risk strategies within enterprise quality management systems. These pieces explore the methodologies and tools. Used by AssurX to identify, assess, and control potential issues across industries, ensuring compliance with standards like ISO 9001 and ICH Q9. Readers will find detailed discussions on Failure Modes and Effects Analysis (FMEA), risk matrices, and the integration with other quality solutions. Such as CAPA, Audit, and Change Management. AssurX’s content is crafted to empower quality management and regulatory compliance professionals. Offering the knowledge needed to enhance organizational resilience, streamline processes, and drive continuous improvement in product quality.

3 10, 2017

Take Action for ISO 13485:2016 Certification Preparedness
Take Action for ISO 13485:2016 Certification Preparedness

Take Action for ISO 13485:2016 Certification Preparedness

By Sal Lucido|2017-10-03T10:29:52+00:00October 3rd, 2017|FDA Regulated Industries, Regulatory Compliance Management, Risk Management|

ISO 13485 has undergone its first major overhaul of manufacturing system require [...]

10 04, 2017

China Addresses Life Sciences Regulatory Compliance Concerns
China Addresses Life Sciences Regulatory Compliance Concerns

China Addresses Life Sciences Regulatory Compliance Concerns

By AssurX Blog|2017-04-10T13:44:24+00:00April 10th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

China has often faced criticism for lax regulation of drug and medical device ma [...]

3 04, 2017

FDA Warning Letters Emphasize Document Control System Compliance
FDA Warning Letters Emphasize Document Control System Compliance

FDA Warning Letters Emphasize Document Control System Compliance

By AssurX Blog|2025-04-03T01:32:10+00:00April 3rd, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize [...]

28 03, 2017

FDA States Clear cGMP Expectations for Combination Products
FDA States Clear cGMP Expectations for Combination Products

FDA States Clear cGMP Expectations for Combination Products

By AssurX Blog|2017-03-28T08:51:56+00:00March 28th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

The Food and Drug Administration (FDA) recently released a final guidance on Cur [...]

14 03, 2017

Cybersecurity Management Expectations Clarified By FDA
Cybersecurity Management Expectations Clarified By FDA

Cybersecurity Management Expectations Clarified By FDA

By AssurX Blog|2017-03-14T11:01:57+00:00March 14th, 2017|Archives, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

The FDA has made it abundantly clear that it expects medical device manufacturer [...]

6 02, 2017

NERC CIP Cybersecurity Risk Management: Being Proactive in 2017
NERC CIP Cybersecurity Risk Management: Being Proactive in 2017

NERC CIP Cybersecurity Risk Management: Being Proactive in 2017

By AssurX Blog|2017-02-06T13:45:46+00:00February 6th, 2017|Archives, Energy & Utilities Industry, NERC Compliance, Regulatory Compliance Management, Risk Management|

NERC CIP cybersecurity risk management efforts by savvy utility grid operators h [...]

30 01, 2017

Risk Management Best Practices for Cybersecurity Compliance
Risk Management Best Practices for Cybersecurity Compliance

Risk Management Best Practices for Cybersecurity Compliance

By AssurX Blog|2017-01-30T01:59:17+00:00January 30th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

A new FDA guidance concerning risk management helps medical device manufacturers [...]

16 01, 2017

Risk Management + Quality Metrics Reporting: Revised FDA Guidance
Risk Management + Quality Metrics Reporting: Revised FDA Guidance

Risk Management + Quality Metrics Reporting: Revised FDA Guidance

By AssurX Blog|2017-01-16T12:48:28+00:00January 16th, 2017|Archives, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Risk management remains a strong focus of the FDA. A revised FDA guidance offers [...]

31 12, 2016

Part I: Enterprise Quality Management System Selection Best Practices

By AssurX Blog|2016-12-31T09:58:14+00:00December 31st, 2016|Archives, Quality Management, Regulatory Compliance Management, Risk Management|

Editor's Note: In this two-part series, you'll learn common pitfalls to avoid an [...]

16 12, 2016

Risk Management + Adverse Event Reporting: FDA Guidance
Risk Management + Adverse Event Reporting: FDA Guidance

Risk Management + Adverse Event Reporting: FDA Guidance

By AssurX Blog|2016-12-16T10:21:33+00:00December 16th, 2016|Archives, eMDR, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Risk management and adverse event reporting protocols for medical device manufac [...]