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Research & Development

Successful Medical Device Design Transfers Hinge on Advance Planning

Elements of a well-constructed plan include an understanding of regulatory requirements, a comprehensive review of all documentation and a thorough understanding of manufacturing methods and processes.

Start Simple: Advice to Effectively Use Statistical Methods in Process Validation

Thorough process development, optimization and control using appropriate statistical methods and tools is recommended to show that processes are stable and capable.

Extremities Players Seek to Bolster Shoulder Revenue with Stemless Implants

Exactech’s FDA-cleared Equinoxe is competition for Wright Medical and Zimmer Biomet’s offerings. The three are the only FDA-cleared stemless shoulders in the U.S.