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Biocompatibility & Testing
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Biocompatibility & Testing
Changes Involving Biocompatibility Testing for Medical Devices—An Orthopedic Innovators Q&A
Shifting requirements from both the FDA and in the EU have generated significant questions around the laboratory evaluation of devices.
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Biocompatibility & Testing
Updates to Conducting Toxicological Risk Assessment of Medical Device Constituents
A description of new terms and their use in the toxicological risk assessment paradigm of medical device constituents.Sharlee L. More, Ph.D., DABT, Associate Director, Toxicology, Regulatory Affairs, MCRA LLC 11.13.23
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Biocompatibility & Testing
The Transition to MDR and Important Considerations—An Orthopedic Innovators Q&A
With the delays seemingly settled, orthopedic device manufacturers need to ensure they are aligned to the EU’s MDR.
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Biocompatibility & Testing
Patient-Specific Implants and Proper Testing of Them—An Orthopedic Innovators Q&A
Customizing implants to a specific patient can provide fit and function advantages, but can present uncertainty with regard to testing.
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Biocompatibility & Testing
Leveraging Automation to Improve Inspection Quality—An Orthopedic Innovators Q&A
Automation not only addresses labor shortage concerns, but also enhances the overall output by improving the inspection process.
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Biocompatibility & Testing
Lab Tested, Industry Approved: A Discussion of Ortho Device Testing & Analysis
A group of medical/orthopedic device testing experts discuss the impacts of industry trends on their businesses.Sam Brusco, Associate Editor 09.12.23
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Biocompatibility & Testing | Design
Exploring Issues Surrounding Quality Control & Device Design for Osteoporosis Testing & Monitoring
What are the potential solutions and how can manufacturers and orthopedic professionals provide patients with the best outcomes?Online Exclusives Amanda Winstead, Freelance Writer 08.30.23
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Assembly & Automation | Biocompatibility & Testing
Leveraging Automated Inspection to Counter Labor Shortages
We can no longer assume competitive pay alone will be enough to attract and retain quality employees.Brad Traczyk, Orthopedic Quality Manager, Lowell Inc. 08.04.23
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Biocompatibility & Testing | Spine/Neurology
Lifespans Launches Alfonso Cloud
The SaaS simulation platform dramatically reduces the time and cost of the implant testing process, setting a new standard for bringing new implants to market.Charles Sternberg, Associate Editor 05.15.23
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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.
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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
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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.
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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
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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
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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
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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.
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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
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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
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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
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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
