EU CRA, Medical-Device MDR & FDA — Three Free Security-Compliance Courses
Taiwan's first medical-device security training taught directly by Applus+ Laboratories — presented by Secure Vectors Surveillance × Applus+, so you master the compliance essentials before CRA vulnerability reporting takes effect and the MDR transition sunsets.
See the three free courses ↓Three Clocks Counting Down at Once — the Regulatory Threshold Is at the Door
EU and US security requirements have shifted from nice-to-have to market-entry condition
CRA Vulnerability Reporting Takes Effect
Manufacturers discovering an actively exploited vulnerability must notify the national CSIRT and ENISA within 24 hours, with a full report within 72 hours.
CRA Fully Applicable
Every product with digital elements (PDE) entering the EU must comply. Fines up to €15 million (≈ NT$510 million) or 2.5% of global annual revenue, whichever is higher.
MDR Transition Period Sunsets
High-risk devices must complete MDR certification by Dec 31, 2027; low- and medium-risk by Dec 31, 2028. The world's ~50 notified bodies now queue 12–18 months.
Three Courses · Three Roles · Compliance Covered in One Pass
Pick what you need — decision-makers, engineering, quality
EU CRA Update & Analysis
Vulnerability reporting starts September 2026 — can your product still enter the EU?
- Front-line observations from Applus+ at the EU standards table
- CRA timelines, penalties and risk classes (default / important / critical) in one hour
- Where CRA, RED 3.3 and EN 18031 each apply — three parallel tracks untangled
- How to build a vulnerability-reporting SOP that meets the 24/72-hour bar
MDR Medical-Device Security Hands-On Workshop
FDA and MDR submissions keep bouncing on security documents — this course spares you the detours.
- IEC 81001-5-1 security life-cycle framework and gap analysis
- Hands-on SBOM building (SPDX / CycloneDX formats)
- Threat-modeling methods and TARA report output
- The notified-body view of MDR Annex I §17 + MDCG 2019-16
- FDA Section 524B submission pitfalls and SBOM requirements
ISO 13485 Internal Auditor Training
Rare in the industry: quality and security internal audit, combined
- ISO 13485:2016 clause walkthrough (mapped to the new FDA QMSR)
- The must-learn add-on: a security audit module — bringing IEC 81001-5-1 into your QMS
- Audit planning, checklist authoring and findings handling in practice
- Common notified-body audit rejection causes and responses
- Certificate of attendance on completion
Upcoming Sessions
Open a course card for the full schedule · registration closes when full · early sign-up recommended
| Date | Topic | Time | Format | Status | Materials |
|---|---|---|---|---|---|
| 2026/09 — TBA | CRA topic to be announced | 14:00–15:00 | Online | Open | — |
| 2026/06/30 | Facing the EU CRA: a deep dive into horizontal standards prEN 40000-1-2 & prEN 40000-1-3 | 14:00–15:00 | Online | Ended | Watch recording |
| Date | Topic | Time | Venue | Status | Materials |
|---|---|---|---|---|---|
| 2026/08 — TBA | Topic to be announced | 13:30–17:30 | Secure Vectors office, Taipei | Open | — |
| 2026/06/13 | MDR Annex I §17 + FDA 524B security requirements, side by side | 13:30–17:30 | Secure Vectors office, Taipei | Ended | Watch recording |
| Date | Topic | Time | Venue | Status | Materials |
|---|---|---|---|---|---|
| 2026/09 — TBA | Topic to be announced | 13:30–17:30 | Secure Vectors office, Taipei | Open | — |
| 2026/05/16 | ISO 13485:2016 clause walkthrough + FDA QMSR mapping | 13:30–17:30 | Secure Vectors office, Taipei | Ended | Watch recording |
Why Secure Vectors Surveillance + Applus+ Laboratories?
Plenty of similar training exists in Taiwan — these four things, only we can offer
Taiwan First | Taught by Applus+
Applus+ Laboratories has never run public training in Taiwan before. These three courses are its first set taught directly, with content brought straight from the EU front line.
Dual Expertise: Medical Devices + Security
Some firms do quality without security; others do industrial security without medical devices. Secure Vectors Surveillance is Taiwan's only combination of a medical-device regulatory consultancy and an ISO/IEC 17025-accredited security laboratory.
An Attacker's Mindset from Finance
Most instructors come from safety or IT engineering. We come from financial payment security — where attackers are the richest, most professional and most motivated — and we bring that mindset to medical-device security.
Three Markets in One Course
MDR, FDA Section 524B, China NMPA YY/T 1843 — one SBOM, one threat model, one set of security documents can serve all three markets at once. A perspective you will not find elsewhere.
Frequently Asked Questions
What you might want to know before registering
Completely free, with no hidden fees (in-person sessions include light refreshments). The three courses are designed to complement each other — CRA builds the regulatory big picture, MDR focuses on hands-on security, ISO 13485 integrates quality and security — so we strongly recommend registering for all three. Just tick every course you are interested in on the form.
Each course has its own recommended audience. CRA Update: for every maker of connected or consumer-electronics products (including industrial control and IoT), designed for decision-makers — no medical-device background required. MDR workshop and ISO 13485 auditor training: focused on the medical-device field (including IVDR products); basic device-development or QA experience is recommended for full benefit. If your products span both medical and general connected tracks, we especially recommend all three.
In-person workshops are held at the Secure Vectors office in Taipei. After you submit the form, we confirm registration and screening results by email 7–10 working days before the session, with detailed directions. To protect quality, in-person sessions are by application, limited to 3 people per company; once a session fills, you are given priority for the next one.
Attendees who complete a full course receive a joint Secure Vectors Surveillance × Applus+ certificate of attendance. (If you need IRCA lead-auditor qualification, we can also refer you to the relevant international certification courses.)
“Directly taught” means the materials, cases and regulatory views come from Applus+ Laboratories’ official resources — a rare chance for Taiwanese manufacturers to work with a leading global testing, inspection and certification body without flying overseas. For groups of 8 or more, we also offer paid in-house training, with content and hours customized to your product type — contact our sales team to discuss.
The countdown has started — moving on enforcement day is too late
Three courses, three roles, compliance in one pass. Register now and we will notify you of the next session for the courses you choose.
Register now ★Secure Vectors Surveillance Inc.
ISO/IEC 17025-accredited security laboratory & Applus+ Laboratories Alliance Partner.