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Nelson Laboratories LLC

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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.

Released By Nelson Laboratories LLC

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.

Released By Nelson Laboratories LLC

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.

Released By Nelson Laboratories LLC

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