Clients of Arthur benefit from his unique combination of academic, industrial, competent authority and business experience in medical devices and in vitro diagnostics.
Easy to understand regulatory pathways are delivered in which competent authority preferences are used to optimize input for technical documentation including risk management, design documentation and clinical evaluation reports. The resulting dossiers are ‘reviewer friendly’, supporting fast approval and prompt time to market.
His expertise enables clients to create and execute meaningful quality systems that not only deliver compliance but also provide clear instructions for all employees so they understand their role in their organisation and the value they add to it.
Clients are of all sizes, from multinationals to start-ups. Approvals in the major global jurisdictions are delivered, including US FDA 510K, PMA, CE Marks, and Australian TGA. Operations are expanding into Asia, including direct representation in China.
Need assistance with your Global Medical Device and IVD Regulatory Services?
We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)