Risk Management Software by AssurX

AssurX Risk Management Software enhances the identification, assessment, and control of risks across enterprises. Our platform integrates with quality management systems to automate risk processes, ensuring compliance with standards like ISO 14971 and ISO 9001. Experience improved visibility and decision-making with real-time risk analysis and reporting.

BPM Partners with AssurX to Enhance Cybersecurity and Compliance Solutions for Energy and Utility Industry
BPM Partners with AssurX to Enhance Cybersecurity and Compliance Solutions for Energy and Utility Industry

BPM Partners with AssurX to Enhance Cybersecurity and Compliance Solutions for Energy and Utility Industry

AssurX Blog2026-01-29T21:08:29+00:00February 6th, 2025|

SAN FRANCISCO, Jan. 15, 2025 – BPM LLP, one of the 35 largest public accounting [...]

Implementing Global Data Privacy Compliance Plans
Implementing Global Data Privacy Compliance Plans

Implementing Global Data Privacy Compliance Plans

Paul Fricke2026-01-29T21:15:17+00:00January 28th, 2025|

As businesses continue to embrace digital transformation, cloud computing has e [...]

Mastering Quality: Proven Risk Mitigation Strategies for Flawless Manufacturing
Mastering Quality: Proven Risk Mitigation Strategies for Flawless Manufacturing

Mastering Quality: Proven Risk Mitigation Strategies for Flawless Manufacturing

Stephanie Ojeda2026-01-29T21:19:50+00:00January 23rd, 2025|

Risk mitigation is crucial for manufacturing quality products because it helps [...]

AI in Medical Device Manufacturing: How It’s Transforming an Industry
AI in Medical Device Manufacturing: How It’s Transforming an Industry

AI in Medical Device Manufacturing: How It’s Transforming an Industry

Stephanie Ojeda2026-01-29T21:50:00+00:00December 5th, 2024|

In April 2018, the U.S. Food and Drug Administration (FDA) approved the first A [...]

FDA Inspection Expectations in 2025
FDA Inspection Expectations in 2025

FDA Inspection Expectations in 2025

Stephanie Ojeda2025-04-04T02:22:07+00:00November 21st, 2024|

The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspect [...]

Critical Aspects of Quality Management Systems: Focusing on the Validation Process
Critical Aspects of Quality Management Systems: Focusing on the Validation Process

Critical Aspects of Quality Management Systems: Focusing on the Validation Process

Victoria Alestra2026-01-06T00:15:03+00:00November 14th, 2024|

In regulated industries like pharmaceuticals, medical devices, and food manufac [...]

Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?
Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?

Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?

Stephanie Ojeda2025-04-04T02:28:32+00:00October 30th, 2024|

In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rul [...]

5 Places to Use a FMEA in Your Quality Process
5 Places to Use a FMEA in Your Quality Process

5 Places to Use a FMEA in Your Quality Process

Stephanie Ojeda2025-04-04T01:32:06+00:00October 24th, 2024|

Before any road trip, it makes sense to check your tire pressure along with lev [...]

Risk Management in ISO 13485
Risk Management in ISO 13485

Risk Management in ISO 13485

Stephanie Ojeda2024-06-03T14:04:45+00:00July 26th, 2023|

In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue i [...]

FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls
FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls

FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls

Stephanie Ojeda2024-06-25T18:23:15+00:00December 15th, 2022|

Alignment with the Food Safety Modernization Act (FSMA) is necessary for manufac [...]

Risk Management software