Ea Wright

• I advising clients on the complete life cycle of medical devices in the EU from classification, through clinical investigation, interactions with competent authorities and notified bodies, conformity assessment, packaging and labelling. Particular experience in diagnostic and companion diagnostic devices; • I assist clients in preparation of Compliance Policies and related SOPs and related training activities; • I advise client in relation to promotion and marketing activities including participation in MRCs and PRCs; • I support clients in their interactions with healthcare professionals including consultation agreements, promotion and marketing activities, and investigator-initiated studies; • I assist clients in preparation of quality agreements, critical supply agreements, manufacturing agreements, distribution agreements, clinical trial agreements, and CRO agreements; • I support of clients in audits by competent authorities and notified bodies, including response to audit findings and related discussion with competent authorities and notified bodies; • I assist clients in conduct of regulatory due diligence in transactions and support in preparation of relevant provisions of sales agreements, APAs, and transition services agreements; • I have substantial expertise and experience in litigation before the European Courts of Justice and the EFTA Court.