AI-Enabled Medical Devices: FDA & EU MDR Pathways
Take software and AI medical devices through classification, clinical evaluation and market approval.
Apply GMP to autologous and allogeneic therapies, viral vectors and closed processing.
Quality, regulatory, manufacturing and clinical-engineering professionals in healthcare and life sciences.
Days 1–5 as in the 5-day programme, then:
Add a VR lab to this course: each participant wears a standalone headset and repeats real field tasks in a full-scale virtual site, with step-by-step guidance, scoring and an instructor dashboard. No risk to people or equipment, and no need to shut down a plant.
| Date | Location | Format | Fee |
|---|---|---|---|
| 1–5 Feb 2027 | Barcelona, Spain | Classroom · 5 days | $5,000 |
| 26–30 Apr 2027 | Live online | Live online · 5 days | $2,500 |
| 19–30 Jul 2027 | Seoul, South Korea | Classroom · 10 days | $9,000 |
| 10–14 Oct 2027 | Dubai, UAE | Classroom · 5 days | $5,000 |
| 6–10 Mar 2028 | Sydney, Australia | Classroom · 5 days | $5,000 |
| 29 May – 2 Jun 2028 | Live online | Live online · 5 days | $2,500 |
| 20–31 Aug 2028 | Manama, Bahrain | Classroom · 10 days | $9,000 |
| 13–17 Nov 2028 | London, United Kingdom | Classroom · 5 days | $5,000 |
| 14–18 Jan 2029 | Kuwait City, Kuwait | Classroom · 5 days | $5,000 |
| 9–13 Apr 2029 | Live online | Live online · 5 days | $2,500 |
| 2–13 Jul 2029 | Rome, Italy | Classroom · 10 days | $9,000 |
| 24–28 Sep 2029 | Kuala Lumpur, Malaysia | Classroom · 5 days | $5,000 |
| 18–22 Feb 2030 | New York, USA | Classroom · 5 days | $5,000 |
| 13–17 May 2030 | Live online | Live online · 5 days | $2,500 |
| 5–16 Aug 2030 | Cape Town, South Africa | Classroom · 10 days | $9,000 |
| 27–31 Oct 2030 | Doha, Qatar | Classroom · 5 days | $5,000 |
Take software and AI medical devices through classification, clinical evaluation and market approval.
Design and qualify –80 °C to 2–8 °C supply chains for vaccines, cell therapies and biologics.
Engineer hospitals that can expand capacity, isolate airborne risk and keep critical systems running.
Digital Therapeutics & Health App Regulation: an advanced, practice-led programme for healthcare, clinical and life-sciences professionals, built on current international standards, real case studies and hands-on workshops.
Longevity Medicine & Healthy Ageing Programmes: an advanced, practice-led programme for healthcare, clinical and life-sciences professionals, built on current international standards, real case studies and hands-on workshops.
Biobanking & Biosafety Laboratories: an advanced, practice-led programme for healthcare, clinical and life-sciences professionals, built on current international standards, real case studies and hands-on workshops.