Health Canada Cybersecurity Draft Guidance

Health Canada issued a draft guidance document titled, “Pre-market Requirements for Medical Device Cybersecurity.” Section 1.1 states: “Health Canada considers the inclusion of cybersecurity measures an important consideration in issuing medical device licenses. Therefore, this guidance document provides medical device manufacturers advice on the practices, responses and mitigation measures which can improve the cybersecurity of their device. This guidance also outlines the information to be submitted as part of a medical device licence or licence amendment application to demonstrate that their medical device, consisting of or containing software, is sufficiently secure from intentional or unintentional unauthorized access.” Table 1 lists some design principles to consider. Table 3 lists some types of cybersecurity testing (UL 2900-2-1) to consider including source and binary code analysis using tools. Section 2.2 lists information to include in license application to Health Canada. The full draft guidance is at the link provided: 2018 HealthCanada Draft Guidance Document Pre‐market Requirements for Medical Device Cybersecurity.

Upcoming SoftwareCPR Training Courses:

Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructors: Dr. Peter Rech, Brian Pate

Discount Registration through October 31, 2022.  Reserve your spot!

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Public Course – Dec 12-15, 2022 – Being Agile & Yet Compliant (virtual)

COST: 4 half days for $1,920 per person

HOURS: 11 am until 3 pm EDT each day

TRAINING LOCATION: Virtual – live online

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