Testing

What’s the Point of a Biological Evaluation Report?What’s the Point of a Biological Evaluation Report?

Find out why you need to make sure you have a BER in place.

byJeni Lauer, PhD, Biocompatibility Expert with the Nelson Labs Expert Advisory Services Group

Dec 4, 2024

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1 Min Read

NeuroPace Lennox-Gastaut Syndrome Study Completes Enrollment NeuroPace Lennox-Gastaut Syndrome Study Completes Enrollment

byKatie Hobbins

Dec 4, 2024

1 Min Read

Coatings protect medical devices and instruments

Sponsored Content

Protein Adhesion & Metal Interaction in Medical Diagnostic Equipment Medical Diagnostic Equipment: Protein Adhesion and Metal Interaction

Nov 4, 2024

1 Min Read

Sponsored Content

Inspecting Medical Devices at Scale with Automated Industrial CT Scanning Inspecting Medical Devices at Scale with Automated Industrial CT Scanning

Oct 17, 2024

1 Hr View

Toxic Tampons: Fact vs Fiction Toxic Tampons: Fact vs Fiction

byKatie Hobbins

Sep 16, 2024

1 Min Read

Canyon Labs' new accelerated aging chamber

Medical Device Testing Lab Acquires Accelerated Aging Chamber Medical Device Testing Lab Acquires Accelerated Aging Chamber

Aug 2, 2024

1 Min Read

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Biocompatibility as a Critical Design Input

Biocompatibility as a Critical Design Input

Photo Hamilton Medical's Hamilton-G5 medical ventilators

Could Better Software Testing Have Prevented a Death?

Could Better Software Testing Have Saved a Life?

byAmanda Pedersen

Clinical trial

Regulatory & Quality

Women Still Underrepresented in Medical Device Clinical Trials

Women Still Underrepresented in Medical Device Clinical Trials

byKatie Hobbins, Managing Editor

Tested coatings keep in-vivo parts and other biotech safe

Sponsored Content

The Importance of USP Class VI Testing

The Importance of USP Class VI Testing

byPatrick Dick, Technical Sales

MathWorks Medical Devices Industry Manager Dr. Visa Suomi

Could Simulation Advance Your Testing Programs?

Could Simulation Advance Your Testing Programs?

Shape Memory Medical staff

New Technologies

Study Examines Use of Shape-Memory Polymer to Treat Pelvic Venous Disease

Study Examines Use of Shape-Memory Polymer to Treat Pelvic Venous Disease

5 Tips for Choosing a Reliable Testing Partner for Regulatory Success

"Selecting a Reliable Third-party Testing Partner: 5 Tips for Ensuring Successful Regulatory Submissions

byNick Christiano, Global Segment Leader - Biological Safety

Beating Heart

BrioHealth Score IDE Approval for BioVAD System Trial Enrollment

BrioHealth Score IDE Approval for BioVAD System Trial Enrollment

byKatie Hobbins, Managing Editor

Sanguina AnemoCheck Home at-home anemia test

Medical Test Kits Find a New Home

Medical Test Kits Find a New Home

byLisa McTigue Pierce, Executive Editor

Experimental setup used for the experiments

Study: SLSC Photoacoustic Imaging to Reduce Skin Tone Bias

Study: SLSC Photoacoustic Imaging to Reduce Skin Tone Bias

byKatie Hobbins, Managing Editor

auditing process validations

Solving Problems Amid Auditing Process Validations

Solving Problems Amid Auditing Process Validations

byBob Kronemyer

ISO 10993-1

Regulatory & Quality

Complete Rewrite of ISO 10993-1 Creates Industry Buzz

Complete Rewrite of ISO 10993-1 Creates Industry Buzz

byHelin Raagel, Thor Rollins

A Look at Updated Standards for Reusable Medical Devices

A Look at Updated Standards for Reusable Medical Devices

byBob Kronemyer

ISO 10993-17, ISO 10993-18

ISO Chemical Characterization for Medical Devices

ISO Chemical Characterization for Medical Devices

byNate Fredrick, Toxicologist – Expert Advisory Services

Medical technology

Regulatory & Quality

High-Quality (Level 4) PMCF Surveys: What Are They?

High-Quality (Level 4) PMCF Surveys: What Are They?

Sponsored Content

Achieving an Animal-Free Biological Safety Evaluation of Your Medical Device

Achieving an Animal-Free Biological Safety Evaluation of Your Medical Device

FDA approval

Regulatory & Quality

Study Suggests Increased Number of PMA Supplements Increase Recall Risk

Study Suggests Increased Number of PMA Supplements Increase Recall Risk

byKatie Hobbins, Managing Editor

semiconductor manufacturing

Picking A Semiconductor Aging Test Method

Picking A Semiconductor Aging Test Method

byKatie Hobbins, Managing Editor

Clinical trial

Regulatory & Quality

FDA to Require Diversity Action Plan for Clinical Trials

FDA to Require Diversity Action Plan for Clinical Trials

byKatie Hobbins, Managing Editor

Medical Device Regulations

Illumina Could Face Hefty Fine Over Grail Acquisition

Illumina Could Face Hefty Fine Over Grail Acquisition

Untitled design (3).jpg

New Technologies

This Company Wants You to Pee on Its New Device

This Company Wants You to Pee on Its New Device

byKatie Hobbins, Managing Editor

Understanding the Testing Behind Drug Delivery Devices

Understanding the Testing Behind Drug Delivery Devices

Sponsored Content

Find Wireless (BLE/WAN) Medical Device Defects Quickly with OTA Signaling Testing

Find Wireless (BLE/WAN) Medical Device Defects Quickly with OTA Signaling Testing

monkeypoxtest (1).jpg

A Monkeypox PCR Test Is in the Works

A Monkeypox PCR Test Is in the Works

byKatie Hobbins, Managing Editor

Visby Puts PCR Testing in the Palm of a Patients Hand

Visby Puts PCR Testing in the Palm of a Patients Hand

Test Electronics as Early as Possible

Test Electronics as Early as Possible

manufacturing professionals working on ISO certification.png

A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices? 50787

A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices?

An At-Home Collection Device for Diabetes Risk Testing

An At-Home Collection Device for Diabetes Risk Testing

medical devices biocompatibility testing

Assessment of Medical Devices Without Animal Experiments

Assessment of Medical Devices Without Animal Experiments

byDr. Christoph D. Lindner, Team Manager, Medical Device Testing

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