Testing

Putting the ‘Management’ into Quality Management System

Putting the ‘Management’ into Quality Management System Putting the ‘Management’ into Quality Management System

Three ways to demonstrate management oversight within your QMS.

Mar 11, 2016

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1 Min Read

Senators Push CMS to Get UDIs onto Insurance Forms

Medical Device Regulations

Senators Push CMS to Get UDIs onto Insurance Forms Senators Push CMS to Get UDIs onto Insurance Forms

byChris Newmarker

Mar 11, 2016

1 Min Read

Vascular Solutions CEO 'Outraged' by Federal Prosecution

Medical Device Regulations

Vascular Solutions CEO 'Outraged' by Federal Prosecution Vascular Solutions CEO 'Outraged' by Federal Prosecution

Mar 4, 2016

1 Min Read

Olympus to Pay Whopping $646 Million over Endoscope Kickbacks

Medical Device Regulations

Olympus to Pay Whopping $646 Million over Endoscope Kickbacks Olympus to Pay Whopping $646 Million over Endoscope Kickbacks

byChris Newmarker

Mar 1, 2016

1 Min Read

High-Res X-Ray Vision for Spotting Product Defects

High-Res X-Ray Vision for Spotting Product Defects High-Res X-Ray Vision for Spotting Product Defects

Feb 13, 2016

1 Min Read

Biocompatibility Safety Assessment of Medical Devices: FDA, ISO, and Japanese Guidelines

Biocompatibility Safety Assessment of Medical Devices: FDA, ISO, and Japanese Guidelines Biocompatibility Safety Assessment of Medical Devices: FDA, ISO, and Japanese Guidelines

Feb 1, 2016

1 Min Read

Medical Device Regulations

7 Medical Device Failures Causing Serious Recalls

7 Medical Device Failures Causing Serious Recalls

FDA Guidance for ISO 10993-1: What to Expect

FDA Guidance for ISO 10993-1: What to Expect

FDA Guidance for ISO 10993-1: What to Expect

Medical Device Regulations

510(k) Process Implicated in Vena Cava Filter Deaths

510(k) Process Implicated in Vena Cava Filter Deaths

Medical Device Regulations

Medtronic Recalls Nearly 100,000 Pacemakers

Medtronic Recalls Nearly 100,000 Pacemakers

Medical Device Regulations

USB Port Glitches in Medical Devices Trigger Recalls

USB Port Glitches in Medical Devices Trigger Recalls

Top 5 Medical Device Dangers to Avoid in 2016

Top 5 Medical Device Dangers to Avoid in 2016

Medical Device Regulations

Risk Management for Medical Devices: An Introduction to the Process [Infographic]

Risk Management for Medical Devices: An Introduction to the Process [Infographic]

How the ISO 9001:2015 Revision Affects Medical Device Companies

How the ISO 9001:2015 Revision Affects Medical Device Companies

How the ISO 9001:2015 Revision Affects Medical Device Companies

Up to Code: Implementing a Quality System

Up to Code: Implementing a Quality System

Up to Code: Implementing a Quality System

How Metrology Is Solving Its Shadow Puppet Problem

How Metrology Is Solving Its Shadow Puppet Problem

Better Animal Testing Alternatives Are Coming to U.S.

Better Animal Testing Alternatives Are Coming to U.S.

Medical Device Regulations

Cook Medical Catheter Recall Is Really Serious

Cook Medical Catheter Recall Is Really Serious

byChris Newmarker

Reconciling Gaps Between Premarket Testing and Postmarket Results

Reconciling Gaps Between Premarket Testing and Postmarket Results

Reconciling Gaps Between Premarket Testing and Postmarket Results

10 of the Worst Medical Device Recalls of 2015

Medical Device Regulations

10 of the Worst Medical Device Recalls of 2015

10 of the Worst Medical Device Recalls of 2015

St. Jude's Device Leveraging Apple's iPod Touch Wins CE Mark

Medical Device Regulations

St. Jude's Device Leveraging Apple's iPod Touch Wins CE Mark

St. Jude's Device Leveraging Apple's iPod Touch Wins CE Mark

The Moral of This Story? Use Test Method Validation

The Moral of This Story? Use Test Method Validation

The Moral of This Story? Use Test Method Validation

Is Your Validation Master Plan in Shape?

Is Your Validation Master Plan in Shape?

Is Your Validation Master Plan in Shape?

byMarie Thibault

Medical Device Regulations

Premarket vs. Postmarket: Applying Risk Management to Your Device's Entire Lifecycle

Premarket vs. Postmarket: Applying Risk Management to Your Device's Entire Lifecycle

Medical Device Regulations

Smith & Nephew Hit With Warning Letter Over Morcellators

Smith & Nephew Hit With Warning Letter Over Morcellators

Medical Device Regulations

Insurance Companies Question Safety of 510(k) Process

Insurance Companies Question Safety of 510(k) Process

Quality Spending Increasing in Medtech

Quality Spending Increasing in Medtech

Quality Spending Increasing in Medtech

Medical Device Regulations

Olympus Updates Scope Cleaning Procedures After Superbug Deaths

Olympus Updates Scope Cleaning Procedures After Superbug Deaths

byChris Newmarker

Medical Device Regulations

Medtronic Hit With Class I Recall Involving Steerable Sheath

Medtronic Hit With Class I Recall Involving Steerable Sheath

byChris Newmarker

Women’s Health Devices Taken to Task by Citizen Petitions

Medical Device Regulations

Women’s Health Devices Taken to Task by Citizen Petitions

Women’s Health Devices Taken to Task by Citizen Petitions

Medical Device Regulations

How a Tampered MRI Sparked a Huge GE Recall

How a Tampered MRI Sparked a Huge GE Recall

byChris Newmarker

Powered Exoskeletons Deemed Class II Devices

Medical Device Regulations

Powered Exoskeletons Deemed Class II Devices

Powered Exoskeletons Deemed Class II Devices

Medical Device Regulations

Superbug Deaths Stoke Reprocessing Fears

Superbug Deaths Stoke Reprocessing Fears

byChris Newmarker, Brian Buntz

Medical Device Regulations

The New Medtronic Inherits a Class I Covidien Recall

The New Medtronic Inherits a Class I Covidien Recall

Validate Your Process Using Design of Experiments

Validate Your Process Using Design of Experiments

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