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Nelson Laboratories LLC

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6280 South Redwood Road , Salt Lake City, UT, 84123, US

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Orthopedic Innovators

The Need for Lifecycle Evaluations of Orthopedics—An Orthopedic Innovators Q&A

Determining the use life of an orthopedic device can provide a wealth of valuable information for regulatory agencies as well as end users.

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Orthopedic Innovators

What Do FDA Changes Mean for Medtech?—An Orthopedic Innovators Q&A

With the new administration taking over, changing dynamics at CDRH could prove significant to medical device manufacturers.

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Orthopedic Innovators

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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Orthopedic Innovators

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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Orthopedic Innovators

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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