"Science Behind the Best Health"

Bio-tech and Medical Devices

Seminars on topics of medical devices consist of the systemic module describing current medical devices production industry; research and testing process; application and approval requirements; pre- and post-marketing regulations in the field.

Basic Research: Prototype Design or Discovery > Pre-Clinical Development > Clinical Development > Regulatory Filling > Approval & Launch Preparations

Safety: Material Selection, Structure/Activity Relations > Lab and Animal Testing > Human and Animal Testing > Safety Follow up

Medical Utility: In Vitro and Computer Models Evaluation > In Vitro and Animal Models > Human Efficacy Evaluation

Industrialization: Physical Design > Small Scale Production > Manufacturing Scale Up Specification > Mass Production

Application and Approval Process: statements; intended use; device description; environmental testing; comparative performance; clinical performance; biocompatibility; standards; sterility; reusable or single use device control; labeling; kit information Scientific and benefit/risk based decisions that factor into Health Canada's decision to grant market authorization.

Premarket Requirements: Labeling, Registration, Listing Quality system certificate and auditing organizations of Canadian Medical Devices Conformity Assessment System (CMDCAS).International standard ISO 13485 and the corresponding Canadian national standard CAN/CSA-ISO 13485

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