Tuesday, September 30

MedSec Academy 006: Understanding and Integrating IEC 81001-5-1

This course will help with understanding and integrating IEC 81001-5-1 which is gaining significant traction with regulators.

By MedSec

Date and time

Tuesday, September 30 · 6 - 10am PDT

Location

Online

Refund Policy

No Refunds

About this event

Description: IEC 81001-5-1 has been gaining significant traction with regulators like those in Japan and the European Union. It is also referenced by the FDA as an example of a Secure Product Development Framework (SPDF).This course will help with understanding and integrating this standard which can help ensure you are developing and maintaining more secure devices and improve chances for success with regulators.

Event Details:

Lead Presenter - Michelle Jump - Chief Executive Officer
Date: September 30, 2025 (4 hours)
Time: 9:00 AM to 1:00 PM (Eastern Time)
Location: Online

Audience: This course is for medical device cybersecurity team members and regulatory affairs personnel at medical device manufacturers who are looking to better understand IEC 81001-5-1 and its use.

Planned Agenda:

Foundation of the Standard
Understanding the Secure Device Lifecycle
Correlation between 62334 and 81001-5-1
Annex F for Transitional Software
Integration of 81001-5-1 into Processes

Frequently asked questions

In addition to attending the course, do I get anything else from the course?

All attendees will receive the slides from the course. Recordings or transcripts will not be provided.

How will I join the Course?

The Zoom link to join is provided once you register.

I can't attend this date, are there other dates available?

MedSec releases new course dates throughout the year. If you aren't able to attend this date or would like a dedicated offering of the course for your organization, reach out to info@medsec.com.

Organized by

MedSec