Professional profile
About Stefan
Stefan Keller advises medical device and digital health companies on EU MDR and IVDR compliance, software as a medical device classification and China market access from Basel.
Mr. Keller is admitted in Switzerland. He holds a law degree from a Swiss university and has sixteen years of professional experience, working in English, German and French with bar credentials on file.
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SaMD and AI medical software classification follows intended use. Marketing that sells harder can drag a wellness prototype into a device pathway or create false-advertising exposure without a registration home.
He freezes intended-use language in a controlled document and requires medical-legal approval for any claim that diagnoses, triages or treats.
If AI outputs influence clinical decisions, model versioning and hospital override logs are planned from day one. Chinese and English intended-use sentences are locked before the growth team ships claims.
EU MDR and IVDR enforcement against China exporters is mapped with local counsel. Data integrity, technical documentation and post-market surveillance expectations are aligned with the regulatory strategy.
Device files are multi-regulator and multi-contract. Registration classifications, clinical evaluation expectations, labelling and distributor quality agreements must align.
Advertising and KOL promotion of devices is a recurring enforcement theme. Claim language that works in English marketing often oversteps Chinese standards. He pre-clears customer-facing materials and training decks.
Adverse event and recall communications are sequenced with insurer and distributor notice duties so messages stay consistent across markets.
Provide product type, intended use, registration status and target markets. Scope is confirmed in writing through this profile's inquiry channel.
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