Medical Device Industry

The “Medical Device Industry” category at AssurX focuses on the unique needs and challenges of this highly regulated sector. This section provides insights into quality management, regulatory compliance, and process optimization specifically for medical device manufacturers. Topics include navigating complex regulations, ensuring product safety, and improving operational efficiency. With AssurX’s expertise, medical device professionals can maintain compliance, enhance quality, and drive innovation, ensuring products meet stringent industry standards.

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 [...]

23 01, 2017

Tougher Quality Management Enforcement By FDA In 2017
Tougher Quality Management Enforcement By FDA In 2017

Tougher Quality Management Enforcement By FDA In 2017

By AssurX Blog|2017-01-23T10:06:32+00:00January 23rd, 2017|Archives, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Quality management, always an FDA focus during inspections, could become even mo [...]

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 [...]

8 11, 2016

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

Weak CAPA Programs Hit Globally by FDA Warnings

By AssurX Blog|2016-11-08T14:40:29+00:00November 8th, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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.

31 10, 2016

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?

By AssurX Blog|2023-03-08T22:42:36+00:00October 31st, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

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.

24 10, 2016

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

By AssurX Blog|2023-02-27T20:08:48+00:00October 24th, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

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.

14 10, 2016

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

By AssurX Blog|2025-04-04T02:24:31+00:00October 14th, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

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.

27 09, 2016

Cloud for quality and compliance management: A primer for life sciences companies
Cloud for quality and compliance management: A primer for life sciences companies

Cloud for quality and compliance management: A primer for life sciences companies

By AssurX Blog|2024-03-26T20:18:20+00:00September 27th, 2016|Archives, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Here's what life sciences companies moving their quality and compliance management tools to the cloud can expect.

19 09, 2016

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

RAPS Preview: FDA CDRH Director Shuren Talks Priorities

By AssurX Blog|2023-02-28T15:35:39+00:00September 19th, 2016|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

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

5 11, 2015

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

By AssurX Blog|2015-11-05T11:39:30+00:00November 5th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

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