Cybersecurity in Medical Devices Latest Guidance: Quality System Considerations and Content of Premarket Submissions

Talk FDA, the online training platform specializing in FDA-regulated industries, today announced the release of its latest course: "Cybersecurity in Medical Devices: Latest Guidance, Quality System Considerations and Content of Premarket Submissions."

With connected medical devices increasingly targeted by cyber threats and scrutiny from regulators rising, this timely course equips device manufacturers, regulatory affairs professionals, quality assurance teams and software engineers with the knowledge to integrate cybersecurity into quality systems and premarket submissions.

Key highlights of the course include:

- Overview of the current regulatory landscape and latest U.S. Food & Drug Administration (FDA) expectations around cybersecurity for medical devices.

- Applying software lifecycle standards such as IEC 62304 and risk-management frameworks like ISO 14971 within the device development process.

- Building a cybersecurity plan aligned with a quality management system (QMS) and embedding documentation into premarket submissions.

- Practical best-practices for identifying threats, mitigating vulnerabilities in connected medical devices, structuring risk communications and fulfilling reporting requirements.

The course is presented by Cybersecurity expert Carolyn Troiano who brings over 30 years of experience in computer system validation, software compliance and cybersecurity for FDA-regulated industries.

"We designed this course because cybersecurity is no longer optional-it's now one of the top triggers for device recalls and regulatory action," says Carolyn Troiano. "Professionals need to know not only what to build, but how to document it and present it to regulators confidently."

Talk FDA is trusted by pharma, biotech and medical device professionals around the world to deliver up-to-date, expert-led training in regulatory affairs, quality, validation and audits. This new offering strengthens the platform's role in helping device manufacturers stay ahead of evolving regulatory requirements.

Availability & Access
The course is available now on Talk FDA - https://www.talkfda.com/course/cybersecurity...?utm_source=openpr&utm_medium=press_release&utm_campaign=cyber_md_course

Learners receive a certificate of completion and can access the content at their own pace. For a limited time, Talk FDA is offering a discount code: TALKFDA40 (40 % off).

Talk FDA
5939 Candlebrook Court, Mississauga, ON L5V 2V5, CANADA
Ramesh Krishnan
Email: ramesh@compliancectrainings.com
Phone: 4169154458
Website: https://www.TalkFDA.com

Talk FDA is an online learning platform delivering expert-led courses for professionals in FDA-regulated sectors-pharmaceuticals, biotech and medical devices. With flexible, on-demand learning and actionable insights from industry leaders, Talk FDA helps companies and individuals build compliant quality systems, prepare robust submissions and elevate their regulatory strategies.

This release was published on openPR.