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 [...]
Regulatory News Sharpless Outlines FDA’s Key Priorities for Advancing Public Health Acting FDA Commissioner Ned Sharpless sent an email to FDA staff outlining four main priority areas: assuring [...]
Regulatory News CDRH Announces Implementation of Office of Product Evaluation and Quality OPEQ will integrate the premarket and postmarket program functions along products lines to help CDRH [...]
Last week, Simbex CEO Rick Greenwald presented at the ASTM Sixth International Symposium on Safety in Ice Hockey, where he discussed the evolving value of Head Impact Monitoring (HIM) in sports. [...]
Regulatory News FDA Drafts Guidance on Inspections of Medical Device Establishments The three-page draft guidance, which satisfies a requirement established by the FDA Reauthorization Act of [...]
