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Legal, Clinical & Regulatory

Crucial Validation Considerations for Instrument Cases and Trays

Common challenges device company engineers face during validation of delivery systems include case/tray longevity, robustness of design, maintaining integrity of ID markings and establishment of worst-case testing parameters. 

How to Respond to FDA Inspection Observations, Even Those You Dispute

Martin Browning from EduQuest provides insight on responding to Form 483 observations: "It’s critical to show FDA that you are in control of the situation and are attempting to comply voluntarily by doing everything possible and reasonable to ensure that your products meet Agency specifications."

b-ONE Ortho Gains FDA 510(k) Clearance for Total Hip

The b-ONE™ cementless total hip system is the company’s first product following a US $20.0MM round of Series A financing.