Regulatory Compliance

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Regulatory Compliance 2017-05-19T09:25:56+00:00

All protocols and reports generated by Kathy Dumbleton are written to comply with the following standards and guidelines:

Regulatory WMA Helsinki

The World Medical Association’s Declaration of Helsinki

ISO 14155:2011(E) Clinical investigation of medical devices for human participants – Good clinical practice

ISO 19980:2012 (E) Ophthalmic optics – Contact lenses and contact lens care products – Guidance for clinical investigations

ICH E6: Good Clinical Practice: Consolidated guideline, CPMP/ICH/135/95 Good clinical practice; July 1996