Blog

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Regulatory News FDA Drafts Guidance on Inspections of Medical Device Establishments The three-page draft guidance, which satisfies a requirement established by the FDA Reauthorization Act of [...]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

Regulatory News Impact of the USMCA on the Medical Device Industry In the US-Mexico-Canada Agreement (USMCA), the countries committed to avoid duplicative regulatory requirements and coordinate [...]

Simbex CTO, Jeff Chu, and I attended the Consumer Electronics Show in Las Vegas last week.  This year, CES had 180,000 attendees focused on the “next best thing” across too many industries to [...]

2018 Trends in Medical Device Reimbursement Telehealth: improvements in coverage and access No one can ignore telehealth and remote patient monitoring as hot topics for 2018. This year we saw [...]