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2. Sam T. Optimising the therapeutic trinity of active ingredient, delivery system and functional packaging. J Controlled Release. 2003;87:153–7.
3. ISO 13485. Medical devices—quality Management Systems—requirements for regulatory purposes. 2007.
4. ANSI/AAM/ISO 14971. Medical devices—application of risk management to medical devices.
5. ISO 14155. Clinical investigation of medical devices for human subjects—good clinical practice.