News

Regulatory News European Parliament Adopts Second Round of MDR, IVDR Corrigenda This change means that devices (not custom made devices) that are self-certified under the current Medical Devices [...]

Regulatory News Fall Regulatory Agenda: FDA Delays Release of Several Proposed Rulemakings in April 2020, FDA expects to publish a proposed rule on the modernization of the quality system [...]

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 [...]

Rick Greenwald has spent his life working towards making sports and medical devices safer. A couple weeks ago, our CEO, Rick Greenwald went on the Sydcast podcast to talk with Sydney Finkelstein, [...]

Ian Wood has been working with Simbex as a Summer 2019 Marketing Co-op.  

This month, we launched our new website for ActiveStep®. ActiveStep® is an instrumented treadmill that uses rapid belt movements to induce slips, trips, and falls. Based on over 25 years of [...]

Josh Posen has been working with Simbex as a Summer/Fall 2019 Product R&D Co-op.