About this Event
🎟️ Complimentary tickets: enter your exclusive invitation code at checkout, or email [email protected] to request tickets for you and your team. 🍴 Lunch is provided after the session!
Cybersecurity is now part of getting a product to market. The EU’s Cyber Resilience Act (CRA) has required reporting of actively exploited vulnerabilities since September 2026, and from December 2027 its full requirements are part of the CE mark. In the US, the FDA can refuse a medical device submission that arrives without its cybersecurity documentation, and Health Canada expects the same kind of evidence. On the industrial side, more customers now ask their suppliers for IEC 62443.
This morning at MaRS is for companies around Toronto, Waterloo and York Region that build connected, industrial and medical devices. We’ll go through what each of these asks of your product, where they overlap so the same work counts twice, and what to put in place first.
⏳ 𝗪𝗵𝗮𝘁’𝘀 𝗗𝗿𝗶𝘃𝗶𝗻𝗴 𝗜𝘁
🇪🇺 EU: Cyber Resilience Act (CRA)
• Reporting of actively exploited vulnerabilities since September 2026. Part of the CE mark from December 2027.
🇺🇸 US: FDA section 524B
• Cybersecurity documentation, including an SBOM, required in medical device submissions.
🇨🇦 Canada: Health Canada
• Cybersecurity evidence expected in medical device licence applications.
🏭 Industrial and IoT: IEC 62443
• The cybersecurity standard industrial customers ask suppliers for.🇬🇧 UK: PSTI Act
• Security requirements for consumer connected products since April 2024.
🇦🇺 Australia: Cyber Security Act
• Security standards for consumer smart devices since March 2026.
👥 𝗜𝘀 𝗧𝗵𝗶𝘀 𝗳𝗼𝗿 𝗬𝗼𝘂?
- Medical device manufacturers preparing an FDA or Health Canada submission
- Industrial and IoT device makers whose customers ask for IEC 62443
- Companies selling connected consumer or commercial products in Europe, or planning to
- Suppliers of components, modules or software that go into someone else’s product, and companies selling under their own label
- Engineering, R&D, quality, regulatory and product teams, founders and technical leads
🎤 𝗦𝗽𝗲𝗮𝗸𝗲𝗿𝘀
𝗕𝗮𝗯𝗯𝗶𝘀𝗼𝗻 𝗝𝗲𝘆𝗮𝗿𝗮𝘁𝗻𝗮𝗺
Account Manager, Megalab Group Inc.
𝗞𝗵𝗮𝗹𝗶𝗱 𝗧𝗮𝘂𝗳𝗶𝗾 - MBA, PMP®
Cybersecurity/AI Specialist, Megalab Group Inc.
🗓️ 𝗧𝗵𝗲 𝗠𝗼𝗿𝗻𝗶𝗻𝗴
☕ 9:00 AM: Doors Open
• Coffee and registration
🌐 9:30 AM: Cybersecurity Rules Across the EU, US and Canada
• Introduction of Megalab Group Inc.
🔐 10:00 AM: The EU CRA/AI Act, FDA 524B, IEC 62443, UK PSTI, AUS Cyber Security Act in Practice
• CRA scope and classification, SBOM and vulnerability handling, the cybersecurity documentation FDA and Health Canada submissions need, and where IEC 62443 fits for industrial and IoT devices
🤖 11:15 AM: When Your Product Uses AI
• How AI features can bring in the EU AI Act, and where that evidence overlaps with the CRA
📋 11:40 AM: Getting Certified: Who Does What
• From application to certificate, and how certification bodies and notified bodies differ
🍴 12:00 PM: Lunch and Q&A
• Open questions over lunch
𝗔𝗳𝘁𝗲𝗿 𝘁𝗵𝗲 𝗧𝗮𝗹𝗸𝘀
Sign-up for a free one-on-one discovery meeting afterwards on their own product.
📍 𝗟𝗼𝗰𝗮𝘁𝗶𝗼𝗻
MaRS Centre, Collaboration Room 2 (CR-2), South Tower
101 College Street, Toronto, ON M5G 1L7
📅 Monday, November 16, 2026
🕤 9:00 AM to 1:00 PM
𝗛𝗼𝘀𝘁𝗲𝗱 𝗕𝘆
Megalab Group Inc. is the compliance and certification testing lab in Aurora, accredited to ISO/IEC 17025. Our cybersecurity team works with manufacturers on the CRA, FDA and Health Canada submissions, UK PSTI, IEC 62443, SBOMs and product security testing, alongside the EMC, product safety and environmental testing Ontario companies already know us for.
✅ 𝗦𝗮𝘃𝗲 𝗬𝗼𝘂𝗿 𝗦𝗲𝗮𝘁
Seating is limited to one room, so please register early.
Event venue & nearby stays
MaRS Centre South Tower, 100-101 College St, Toronto, Canada
Concerts, fests, parties, meetups — all the happenings, one place.