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.

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

FDA’s New 510(k) Guidance Emphasizes Software as Device Factor
FDA’s New 510(k) Guidance Emphasizes Software as Device Factor

FDA’s New 510(k) Guidance Emphasizes Software as Device Factor

AssurX Blog2023-03-06T18:24:19+00:00September 14th, 2015|

The path to medical device commercialization requires FDA approval, which most o [...]

Regulatory Compliance Management

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

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

RAPS Preview: FDA CDRH Director Shuren Talks Priorities

RAPS Preview: FDA CDRH Director Shuren Talks Priorities

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

Improving FDA Reviews of Combination Products

Improving FDA Reviews of Combination Products

FDA Guidance Answers (Some) Medical Device Cybersecurity Concerns

FDA Inspectors Leave Calling Cards For Medical Device Manufacturers Nationwide

FDA Touts Improved IDE Review Stats

Got Patient Care Ideas? FDA Wants to Hear Them

FDA’s New 510(k) Guidance Emphasizes Software as Device Factor

FDA’s New 510(k) Guidance Emphasizes Software as Device Factor