Steve Silverman
Latest From Steve Silverman
Opinion: The Sky Is Not Falling – There's Time To Prep for Quality Management System Regulation's Launch
The US Food and Drug Administration's upcoming switch from the familiar Quality Systems Regulation (QSR) to the new Quality Management System Regulation (QMSR) is enough to strike fear into the heart of many a device maker. But the rollout may prove smoother than some have warned, consultants Steve Silverman and Eric Henry say. Find out what's to come in this Medtech Insight exclusive.
Opinion: At Least It’s Not Fruitcake – My Annual FDA Predictions
Consultant (and former FDAer) Steve Silverman is back with a reflection on his predictions for 2023, and well as what he expects to see in the coming year.
Opinion: Smart Device Firms (and Investors) Unwind Regulatory Risk
Investments in medtech firms have been drying up, with some speculating the reason lies in the degree of regulatory uncertainty inherent to the field. In this opinion piece, consultant and former FDAer Steve Silverman describes how device companies can help investors clarify the risk.
Opinion: Getting Work Done in the ’New Normal‘ CDRH
In this op/ed, consultant and former FDA official Steve Silverman reveals how medical device firms can best interact with the US Food and Drug Administration's Center for Devices and Radiological Health as the COVID-19 pandemic recedes.
Opinion: Happy New Year – the Sequel
In this op/ed, consultant and former FDA official Steve Silverman looks at what he got right – and wrong – in his predictions for 2022 and walks us through his expectations for the new year.
Opinion: Digital Health Precertification -- The Little Engine That Couldn’t (Yet)
In this op/ed, former US FDA device compliance chief Steve Silverman argues that while the agency's digital health precertification (Pre-Cert) pilot program failed to make much of a splash, the concept deserves a second look -- and more Congressional support.