Ten years ago, the FDA’s Premarket Cybersecurity guidance was nine pages; today, the latest premarket guidance is 57 pages long and covers premarket cybersecurity activities and includes activities to be performed during the post-market life of your device.
Are you ready? Some of these new activities need to be in place from the start of a new medical device project; others affect how cybersecurity-sustaining activities are performed. Maybe you’re just preparing for your clinical trials. Do you know what is optional for cybersecurity during your trials required for your production version of the new device?
Don’t wait too long into the development process, as many of these new cybersecurity activities will be costly and impactful to your new design if performed late in development.
If you have heard that the FDA is now enforcing new cybersecurity requirements but have put it off because of all the other mandates of creating a new medical device, then this presentation is for you. Garrett Schumacher, Technical Director of Cybersecurity at Velentium, will address this critical topic Wednesday, February 7 at 10:15 am.
More From SAE Media Group
Medical Design Briefs INSIDER
FDA Recommends Cybersecurity Measures for Device Manufacturers
Medical Design Briefs
From the Editor — A Look Back, and Ahead
Medical Design Briefs
Risk Management for Cybersecure Networked Medical Devices
Medical Design Briefs
The Impact Of Cybersecurity Within The Healthcare Industry
Medical Design Briefs
From the Editor — The MDDT Program: Streamlining Medical Device Approval
Medical Design Briefs
FDA Establishes Advisory Committee on Digital Health Technologies
Medical Design Briefs INSIDER
FDA Proposes Early Warning for Device Safety Failures
Medical Design Briefs INSIDER
FDA Seeks Comments on Refurbishing of Medical Devices
Medical Design Briefs
From the Editor - FDA’s Final Rule on LDTs Raises Concerns for Personalized Medicine
Medical Design Briefs INSIDER
MD&M Session Highlight Experts Present Next Steps for Harmonized Medical-Grade Materials
Medical Design Briefs
From the Editor - FDA's LDT Regulation Must Balance Safety and Innovation
Medical Design Briefs
UDI at 10: Moving into The Future
Medical Design Briefs
From the Editor - Bipartisan Legislation Could Fast-Track Breakthrough Medical Devices
Medical Design Briefs
MEDevice Silicon Valley, an MD&M Event
Medical Design Briefs
From the Editor - Cybersecurity: Playbook for Threat Modeling Medical Devices
Medical Design Briefs INSIDER
Medtech Theater: U.S. Food and Drug Administration to Adopt ISO 13485
Medical Design Briefs
Changes at FDA and New Publication Launch
