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Meet the Psephos Team

Monika Schoenleber-Lewis

Regulatory and Quality Consultant

Monika has over 16 years’ experience supporting medical device companies ranging from start-ups to global manufacturers. She completed her PhD at the University of London, specialising in medical device development.


At Psephos, Monika specialises in Technical File compilation and remediation for CE marking under MDR and UKCA requirements, alongside the implementation and maintenance of ISO 13485 Quality Management Systems.

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