RAPS runs a short virtual workshop mapping medical device cybersecurity requirements onto ISO 13485:2016 quality management system clauses, held mid-November 2026 — RAPS's own pages disagree by a day on the exact date, disclosed below rather than guessed at.

Date and format

  • Date: 11 November 2026, 9:30–11:30am EST, per RAPS's dedicated event page — RAPS's own events-listing page states 12 November 2026 for what otherwise appears to be the same workshop; the discrepancy is unresolved
  • Format: virtual
  • Organizer: Regulatory Affairs Professionals Society (RAPS)
  • Registration: via RAPS's workshop page; regular pricing $240 members / $285 non-members through 11 November 2026

What it covers

The workshop addresses the gaps, if any, in the current ISO 13485:2016 quality management system standard for averting cybersecurity threats and ensuring data integrity, and asks which ISO 13485 clauses cybersecurity guidelines fall under. The published agenda runs through a welcome and overview, the regulatory landscape for medical device cybersecurity, an overview of ISO 13485:2016 itself, mapping cybersecurity requirements to specific ISO 13485 clauses, and a closing gap analysis of the standard's limitations for cyber devices — including what other standards a device needs to meet FDA cyber device requirements.

Who should attend

Quality and regulatory affairs professionals who own a medical device QMS and need a working map from FDA cyber device requirements onto ISO 13485:2016 clauses, rather than treating cybersecurity and quality management as separate programs.

It sits alongside RAPS's broader cybersecurity programming, including its Cybersecurity Unauthorized workshop; the full events directory lists every RAPS session we have verified.

Frequently asked questions

When is the RAPS ISO 13485:2016 cybersecurity workshop?

RAPS's dedicated event page states 11 November 2026, 9:30-11:30am EST, virtual. RAPS's own events-listing page states 12 November 2026 for what otherwise appears to be the same workshop — the one-day discrepancy is unresolved; check RAPS's own page before planning around it.

Who runs the workshop?

The Regulatory Affairs Professionals Society (RAPS).

What does the workshop cover?

It addresses gaps in the ISO 13485:2016 quality management system standard for averting cybersecurity threats and ensuring data integrity: the regulatory landscape for medical device cybersecurity, an overview of ISO 13485:2016, mapping cybersecurity requirements onto specific ISO 13485 clauses, and a gap analysis of the standard's limitations for cyber devices.

Who should attend?

Quality and regulatory affairs professionals responsible for a medical device QMS who need to map FDA cyber device requirements onto ISO 13485:2016 clauses.

Is there a fee?

Per RAPS's own page, regular pricing from 11 October to 11 November 2026 is $240 for RAPS members and $285 for non-members; an earlier-bird rate ended 10 October 2026.

Sources & further reading

  1. RAPS. Workshop: ISO 13485:2016 Addressing Cybersecurity Challenges, 11/11/2026 (RAPS's events-listing page states 11/12/2026). raps.org

Event details are published by the organizer and can change. This listing was verified via WebSearch corroboration of RAPS's own pages rather than a direct fetch, because this session's network egress could not reach raps.org directly; RAPS's own dedicated event page and its separate events-listing page disagree by one day on the date, disclosed above rather than resolved by guessing — confirm date, format and registration with RAPS before making plans. Last verified 31 October 2026.