A client recently told me, “Your team approaches product development problems differently than others – and it worked. You uncovered several critical risks we hadn’t anticipated.” Good to hear, [...]
Regulatory News Device Firms Discuss Ethylene Oxide Sterilization Ahead of FDA Committee Meeting On 6 and 7 November, FDA medical devices advisory committee will meet to discuss the use of [...]
Simbex’s NIH-Funded Center for Translation of Rehabilitation Engineering Advances and Technology (TREAT) program was named a winner of the U.S. Small Business Administration’s 2019 Growth [...]
Regulatory News De Novo Requests: FDA Finalizes Three Guidances FDA finalized three guidance documents related to de novo classification requests for medical devices. The first guidance deals [...]
Regulatory News US FDA medical device user fees increase six percent for 2020 FDA medical device user fees for 510(k) premarket notifications, Premarket Approvals (PMAs) and other market [...]
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