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Training · Courses

EU CRA, MDR & FDA — taught by the people who assess the files.

Three courses with Applus+ Laboratories, operator of EU Notified Bodies 3121 and 2764. Online or in Taipei.

View courses & register Full details
Sep 11, 2026
CRA incident reporting becomes mandatory
Dec 11, 2027
CRA fully applicable — fines up to €15M or 2.5% of global annual turnover
2027–2028
MDR transition period ends
Our courses

Three courses. Pick yours.

Taught by Applus+ Laboratories experts. Dates and topics update here as sessions are announced.

Open
Free
In Person

MDR Medical-Device Security Workshop

Coming soon

MDR regulatory analysis and connected-device security in practice

For: R&D · software engineers · product managers · technical leads
  • 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
Register →
Open
Free
In Person

ISO 13485 Internal Auditor Training

Coming soon

ISO 13485 internal-auditor training for medical-device QMS teams — full agenda announced with the confirmed date.

For: QA · QC · RA · quality leads · regulatory contacts
  • 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
Register →
Open
Free
In Person

EU CRA Update

September 18, 2026 · 14:00 · Taipei

CRA's reporting obligation is now in effect. Applus+ Laboratories' Cybersecurity Business Unit Director Jose Ruiz Gualda joins Taipei in person to share first-hand European conformity assessment insights alongside SVS. Sept 18, limited seats.

For: decision-makers · export sales leads · compliance officers

Speaker · Mr. Jose Ruiz Gualda — Cybersecurity Business Unit Director, Applus+ Laboratories

What your business needs to act on

  • A live discussion with the EU CRA expert flying in from Applus+
  • The 11 September reporting obligation — what changes on the day
  • Which products fall within scope
  • How to handle SBOM and CVE obligations

Session highlights

  • Latest regulatory analysis — CRA timelines, penalties and risk classes
  • The conformity assessment process, module by module
  • Preparing technical documentation that survives review
  • Case studies and open Q&A
Secure Vectors office · 7F., No. 103, Sec. 3, Nanjing E. Rd., Zhongshan Dist., Taipei City 104707
Register →
Ended
Free
In Person

MDR Medical-Device Security Workshop

July 29, 2026

The must-take course for exporting medical devices: MDR regulatory analysis and connected-device security in practice

For: R&D · software engineers · product managers · technical leads
13:30–17:30 · Secure Vectors office, Taipei
Register →
Ended
Free
Live Online

EU CRA Update

June 30, 2026

Facing the EU CRA: a deep dive into horizontal standards prEN 40000-1-2 & prEN 40000-1-3

For: decision-makers · export sales leads · compliance officers
14:00–15:00 · Zoom online
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Ended
Free
In Person

MDR Medical-Device Security Workshop

June 13, 2026

MDR Annex I §17 + FDA 524B security requirements, side by side

For: R&D · software engineers · product managers · technical leads
13:30–17:30 · Secure Vectors office, Taipei
Register →
Ended
Free
In Person

ISO 13485 Internal Auditor Training

May 16, 2026

ISO 13485:2016 clause walkthrough + FDA QMSR mapping

For: QA · QC · RA · quality leads · regulatory contacts
13:30–17:30 · Secure Vectors office, Taipei
Register →
Missed a session? Get the recording ↓
Why this training

Taught by the people who review the files.

Taiwan first — taught by Applus+ Laboratories

The Applus+ Laboratories Notified Body reviewers who assess CRA and MDR files teach the sessions.

Medical devices and security, together

One team, both sides: the regulatory file and the security engineering behind it.

An attacker's mindset from finance

We come from payment security. Every course is taught with that attacker's view.

Aligned across markets

EU MDR, US FDA and China NMPA mapped side by side — one evidence set, every market.

FAQ

Common Questions

Completely free, with no hidden fees — in-person sessions include light refreshments. You can register for more than one course.

CRA sessions: decision-makers, compliance officers, export sales. MDR and ISO 13485 auditor training: medical-device professionals with development or QA background.

At our Taipei lab. Online sessions run on Zoom. Details and confirmation arrive by email after registration.

Attendees who complete a full course receive a joint Secure Vectors Surveillance and Applus+ Laboratories certificate of attendance.

Yes — for groups of eight or more we can arrange dedicated in-house sessions. Contact us to scope the agenda.

Ready to join? Register in one minute.

Every session is free, taught live by Applus+ Laboratories reviewers — online or at our Taipei lab.

Register now