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Posted by on in Design - Development - Manufacturing

Design Control or as the Europeans like to refer to it, Product Realization, is clearly the most critical phase in the product lifecycle.  It requires critical input from Research and Development, Marketing, Manufacturing, Quality, Regulatory, and Clinical (not listed based on importance).  If managed well it will feed off of critical information gathered/created during the Product Idea phase (i.e., Research/Prototyping phase) and create as its first step a clear set of objective design input requirements.  These design input requirements will ultimately evolve into design specifications or outputs.  The ultimate objective evidence that must be produced to satisfy the developer (the medical product company) and 3rd Parties (FDA, Notified Bodies, Competent Authorities, Insurance Companies) is the objective evidence produced during design verification and design validation.  However, it is often the case that the Medical Product Developer and the 3rd Party don’t always think alike.  Even more challenging is the fact that the 3rd Parties themselves often don’t agree what the objective evidence should be (i.e., FDA doesn’t always agree with Notified Bodies/Competent Authorities or vice versa).  Thus the critical need to integrate Regulatory, Clinical, Quality and Insurance Reimbursement demands into the design control/product realization process.  To do this a medical product developer/manufacturer must have integrated operational processes and the current Regulatory, Clinical, Quality and Insurance Reimbursement information/knowledge/experience to assure the creation of the required objective evidence to achieve regulatory approvals and insurance reimbursement coverage.

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