Biocompatibility & Testing

Biocompatibility & Testing

The MDR Delay’s Impact on Regulatory and Testing—An Orthopedic Innovators Q&A

While the recent MDR delay gives companies some breathing room, it should not stall their effort in ensuring their products remain compliant for the EU.

Sponsored released by Nelson Laboratories LLC 03.23.23

Biocompatibility & Testing

Exact Metrology Successfully Scans Titanium Cervical Spine Locking Plate

The METROTOM 6 scout digitizes complex parts including the internal geometries at the finest level of detail.

Charles Sternberg, Associate Editor 01.16.23

Biocompatibility & Testing

An Evaluation of Laboratory Testing for Orthopedic Device Makers—An Orthopedic Innovators Q&A

As devices become more complex and adopt new materials and technologies, manufacturers need laboratory testing partners who can keep pace.

Sponsored released by Eurofins Medical Device Testing 11.15.22

Biocompatibility & Testing

How Statistics Can Reduce Medical Device Inspection Time

Highlighting three statistical methods that can help CMs and OEMs work together to reduce inspection time.

Jack Wieland , Project Manager, Lowell Inc. 09.16.22

Biocompatibility & Testing

Burden of Proof: An Orthopedic Testing & Analysis Roundtable

Seven orthopedic device testing and analysis experts discuss market forces, trends, and challenges in the industry.

Sam Brusco, Associate Editor 09.16.22

Biocompatibility & Testing

The Problem Plaguing U.S. Antimicrobial Joint Implant Development

The regulatory landscape surrounding antimicrobial-associated implants is challenging to navigate.

Dr. Mehdi Kazemzadeh-Narbat, Dr. Sherry Parker and Dr. Kim Ehman, WuXi AppTec 05.26.22

Biocompatibility & Testing

Addressing Chemical Characterization for Medical Devices—An Orthopedic Innovators Q&A

Understanding the make-up of medical devices that have direct contact with the patient is critical to ensure a safe device.

Sponsored released by Nelson Laboratories LLC 04.29.22

Biocompatibility & Testing

AI Tech Requires Customized Clinical Evaluation Strategies

Testing AI’s safety, efficacy, accuracy, cybersecurity, and learning capabilities in the orthopedic arena will be challenging.

Online Exclusives Michael Barbella, Managing Editor 12.10.21

Biocompatibility & Testing

Testing Today’s Orthopedic Devices: A Roundtable Discussion

Besides performance, orthopedic implants must be assessed for their integration and functionality with other product components.

Michael Barbella, Managing Editor 09.14.21

Biocompatibility & Testing

Automated Data Analysis: Making the Case

Shifting to automated data analysis for process qualification activities can improve the effort for manufacturers and their customers in several ways.

Jack Wieland, Project Manager, Lowell Inc. 09.14.21

Biocompatibility & Testing

Disinfectant Efficacy Testing: How Limiting Bioburden Keeps You Compliant

Medical devices are only effective if they can perform their intended functions safely, and safe performance starts with reducing bioburden.

Leslie Tavares, Melinda Johnson and Jessica Lawrence, WuXi AppTec 09.14.21

Biocompatibility & Testing

Human Factors Usability Testing at Home

Online, remote usability testing at home for orthopedic patients has turned out to be a valuable option.

Maria Shepherd, President and Founder, Medi-Vantage 08.17.21

Biocompatibility & Testing

Keys to a Successful First Article Inspection

First article inspection is a necessary step to ensure a manufacturing process will create a medical device that works as designed and meets requirements.

Jack Wieland, Project Manager, Lowell Inc. 08.17.21

Biocompatibility & Testing

Sotera Health Acquires BioScience Laboratories

Strengthens Sotera Health’s antimicrobial and antiviral lab testing capabilities.

Charles Sternberg, Assistant Editor 03.11.21

Biocompatibility & Testing

Lessons from the Lab: Testing Orthopedic Devices

Changes in testing protocols and revised regulatory demands make testing experts even more valuable than they’ve ever been.

Sean Fenske, Editor-in-Chief 09.15.20

Biocompatibility & Testing

Nelipak Facility Earns ISO/IEC 17025 Accreditation

Provides a comprehensive range of testing services to support package testing requirements.

Nelipak 09.10.20

Biocompatibility & Testing

Avoiding Contradictions: Testing Advice for Manufacturers

Manufacturers need to evaluate their approach to preclinical testing. Avoiding contradictory study design is the most effective path forward for study sponsors.

Mark R. Cunningham, Ph.D., Senior Director of Science and Technology, Technical Services, WuXi AppTec 08.11.20

Biocompatibility & Testing