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Legal, Clinical & Regulatory

FDA Finalizes Additive Manufacturing Guidance

FDA published its guidance on additive manufacturing technical considerations, outlining the Agency’s long-awaited position on use of the technology for medical devices.

Examining Methods to Determine Sample Sizes

Consider use of the acceptance sampling approach or the six sigma acceptable error approach to determine a sample size using statistics.  

Why a Well-Conceived Test Plan is Crucial to Efficient Product Development

 

The elements are derived from the biological, mechanical or clinical performance requirements of the device and regulatory requirements for performance and safety.