Will your stand-alone medical device stand up to scrutiny from the FDA’s cybersecurity reviewers? [Photo by Friends Stock via Stock.Adobe.com]
By Normand Martel, MedAcuity
In the highly competitive medical device industry, scientists and engineers are continually pushing boundaries to create innovative medical devices, including stand-alone devices.
The medtech security landscape is rapidly evolving as the FDA introduces changes in regulations that fundamentally redefine the perception and management of security for these devices.
This article aims to demystify the changes to the guidance and security standards. It seeks to empower professionals by providing invaluable insights, enabling you to successfully navigate the complex landscape of regulatory compliance, and fortify security measures when developing stand-alone medical devices.
The premise: Your FDA submission
Let’s say you’re developing a stand-alone medical device (e.g., an aesthetic laser) that is devoid of over-the-air updates or external ports, stores no patient data and authenticates consumables via RfID. Believing in its security due to the absence of a network, you submit a 510(k) package to the FDA,…
