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Standards & certification
Case studies

End-to-end EU Medical Device Regulation training for a global standards body

BSI (British Standards Institution) · 5,000+ employees · Global (London, UK)
  • 5 months from kickoff to full program deployment
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01
Background
BSI is the UK’s National Standards Body and one of the world’s largest certification bodies, operating in 195 countries. BSI’s Training Academy needed an on-demand program covering the EU Medical Device Regulation (2017/745) and CE marking — a commercial training product for medical device professionals preparing for regulatory compliance.
02
The challenge
The MDR is among the most complex regulatory frameworks in healthcare — spanning economic operator responsibilities, conformity assessment, risk classification, clinical evaluation, labelling, and post-market surveillance. BSI had the subject matter expertise but no interactive digital format. Instructor-led delivery couldn’t scale globally, and the Training Academy needed verifiable comprehension — not just content consumption.
03
Our approach
We turned BSI’s SME-provided regulatory content into a fully interactive program, deployed through BSI’s Training Academy LMS. The curriculum spans the full MDR compliance journey — from CE marking fundamentals and economic operator roles through conformity assessment, quality management, clinical evaluation, and post-market surveillance. Learners explore each regulatory domain through layered interactions — examining operator responsibilities, mapping conformity steps to specific MDR chapters, and working through regulatory scenarios. An 80% mastery threshold gates progression, so completion means verified understanding.

2.4x

Annual enrollment capacity vs. instructor-led

84%

Professional completion rate

85%

Assessment pass rate (80% threshold)

New

No digital MDR training to interactive program

Key takeaway

When your training product carries your brand — and your brand sets the standard — the eLearning has to match. Interactive design that verifies comprehension turns regulatory complexity into a credible commercial offering.

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