Sterlingplm.com

FDA’s New Guidance for Cybersecurity in Medical Devices: What it …

WEBIn September 2023, the FDA finalized its medical device cybersecurity guidance for premarket submissions. The updated document, “Cybersecurity in Medical …

Actived: Just Now

URL: https://sterlingplm.com/articles/fdas-new-guidance-for-cybersecurity-in-medical-devices-what-it-means-for-you/

Change Management in the Medical Device Industry

WEBChange management means different things to different people depending on the industry they work in. Thinking about it broadly, change management is the ability to …

Category: Health Go Health

What’s New in ISO 10993-17:2023

WEBThe definition of hazards in ISO 10993-17:2023 emphasizes the elements that potentially cause harm relevant to exposure situations. A trio of criteria play a role in …

Category: Health Go Health

IEC 62304 and the Medical Device Software Development Lifecycle

WEBTo ensure the safe design, development and maintenance of medical software, manufacturers must adhere to the IEC 62304 standard, a framework that …

Category: Medical Go Health

Mobile Medical Device Development

WEBMobile Medical Device Development. Partner with a highly-experienced, focused, and flexible group of experts who will help see your mobile medical device project through to …

Category: Medical Go Health

Medical Device User Interface Design

WEBMedical Device User Interface Design. Sterling brings usability knowledge to the design and development of User Interface (UI) through formative and summative evaluations with …

Category: Medical Go Health