Regulatory Compliance Management

The “Regulatory Compliance Management” category at AssurX is dedicated to helping organizations navigate the complex landscape of regulatory requirements. This section provides practical tools and expert insights to ensure adherence to industry standards and regulations. It covers a range of topics, including compliance strategy development, risk assessment, and the integration of compliance management systems. By exploring these resources, professionals can streamline their compliance processes and mitigate risks effectively. AssurX equips you with the knowledge and solutions needed to maintain compliance and drive operational excellence.

Risk Management Programs: What The Latest Wave of HIPAA Fines Mean
Risk Management Programs: What The Latest Wave of HIPAA Fines Mean

Risk Management Programs: What The Latest Wave of HIPAA Fines Mean

AssurX Blog2016-12-14T15:08:22+00:00December 14th, 2016|

The Department of Health and Human Services (HHS) hit hospitals and other healthcare delivery networks hard in the pocketbook with a wave of big fines zeroing in on security risk management issues between July and October. Is this the end of the fine tsunami? Don't bet on it.

Weak CAPA Programs Hit Globally by FDA Warnings
Weak CAPA Programs Hit Globally by FDA Warnings

Weak CAPA Programs Hit Globally by FDA Warnings

AssurX Blog2016-11-08T14:40:29+00:00November 8th, 2016|

Life sciences companies around the world better make sure their Corrective and Preventive Action (CAPA) plans are in good shape before an inspector comes calling.

Is Your Change Control Program Ready for FDA 510(k) Scrutiny?
Is Your Change Control Program Ready for FDA 510(k) Scrutiny?

Is Your Change Control Program Ready for FDA 510(k) Scrutiny?

AssurX Blog2025-10-02T21:52:01+00:00October 31st, 2016|

A trio of FDA 510(k) guidances demonstrate how important it is for medical device manufacturers to get a firm grip on document management and change control – especially when working within the Third Party (TP) Review Program or trying to determine if a medical device change warrants a new 510(k). The agency is attempting to make it easier on device makers if they understand how to work within the new system.

Ukraine Cyberattack Represents Wake-up Call for America’s Utility Grid
Ukraine Cyberattack Represents Wake-up Call for America’s Utility Grid

Ukraine Cyberattack Represents Wake-up Call for America’s Utility Grid

AssurX Blog2024-07-16T21:25:57+00:00October 24th, 2016|

Still think all of those concerns about cybersecurity protections on the electric grid are overblown? Try asking the 225,000 people in the Ukraine whose power was cut last December by a Russian hacking group that calls itself "Sandworm."

What You Need To Know About the FDA’s Mixed Device PMA Approval Report Card
What You Need To Know About the FDA’s Mixed Device PMA Approval Report Card

What You Need To Know About the FDA’s Mixed Device PMA Approval Report Card

AssurX Blog2023-02-27T20:08:48+00:00October 24th, 2016|

If working with the FDA sometimes feels like reading tea leaves the Quarterly Update on Medical Device Performance Goals gives us more than our usual share of relatively hard data.

How Strong is Your QMS Program? New International Meddev Rules Challenge Complacent Organizations
How Strong is Your QMS Program? New International Meddev Rules Challenge Complacent Organizations

How Strong is Your QMS Program? New International Meddev Rules Challenge Complacent Organizations

AssurX Blog2025-04-04T02:24:31+00:00October 14th, 2016|

It's time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management (QMS) processes - especially document management and change control - will be critical to comply with such a disparate group of regulations working with so many regulatory bodies.

RAPS Preview: FDA CDRH Director Shuren Talks Priorities
RAPS Preview: FDA CDRH Director Shuren Talks Priorities

RAPS Preview: FDA CDRH Director Shuren Talks Priorities

AssurX Blog2023-02-28T15:35:39+00:00September 19th, 2016|

FDA CDRH or Center for Devices and Radiological Health Director Jeff Shuren, MD [...]

FDA Eases Up a Bit on Enforcement Gas Pedal as Warning Letters Decline

AssurX Blog2015-11-05T11:39:30+00:00November 5th, 2015|

Medical device warning letters and domestic inspections continue to show a slow [...]

Improving FDA Reviews of Combination Products
Improving FDA Reviews of Combination Products

Improving FDA Reviews of Combination Products

AssurX Blog2025-10-02T22:00:07+00:00November 3rd, 2015|

The FDA and Intercenter Consultations Just a few short weeks ago, Robert Califf [...]

FDA Guidance Answers (Some) Medical Device Cybersecurity Concerns

AssurX Blog2015-10-29T08:21:17+00:00October 29th, 2015|

A new FDA guidance calls on the medical device community to be more proactive wh [...]