SKY Academy is our free, interactive regulatory training programme for the medical device industry. Both courses are scenario-based: you work through real compliance situations, answer questions and build up progress as you go — no slides, no sign-up fee.
ISO 13485 Academy
Medical device quality management systems, covering ISO 13485:2016 end to end — from scope and definitions through design and development, production, and post-market improvement. 17 modules, 48 lessons, 83 questions.
EU MDR Academy
Regulation (EU) 2017/745 in full — every Article from 1 to 123 and every Annex from I to XVII. Covers classification, conformity assessment, notified bodies, clinical evaluation, post-market surveillance and vigilance. 22 modules, 80 lessons, 145 questions.
Who is it for?
Distributors, regulatory affairs staff, quality managers and anyone bringing a medical device to market in the EU. Your progress is saved on your device, so you can stop and pick up where you left off.
SKY Biotechnology manufactures medical devices in Turkey and exports to healthcare providers in over 50 countries, with CE certification and ISO 13485 quality management. We built these courses from the same material our own team works with every day. Get in touch if you would like to talk about distribution.