Blog

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 [...]

Chen Qiu has been working with Simbex as a Spring 2019 Software/Web Developer Co-op. 

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Regulatory News FDA Drafts Guidance on Inspections of Medical Device Establishments The three-page draft guidance, which satisfies a requirement established by the FDA Reauthorization Act of [...]

Regulatory News CDRH Qualifies 3rd Medical Device Development Tool The OsiriX CDE aims to standardize how health care providers, such as neuroradiologists, mark and classify brain contusions [...]

Regulatory News FDA-tasked Mitre Forges Ahead with Cyber Vulnerability Scoring System Tailored to Devices A new medical device development tool (MDDT) intends to ensure consistency in scoring [...]