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Competitive Device Assessment & Benchmarking
Global Pharmaceutical Company
Client Problem
Understand the look and feel of the competitors' autoinjector devices and respective packaging
Determine to what degree the competitors met FDA and ISO standards, and elucidate the Medical Device Reporting (MDR) procedure
EmPartners' Approach
We procured the actual competitive devices and conducted a technical benchmarking exercise
A detailed mapping of FDA and ISO standard compliance and failures was composed.
Primary was conducted to map out a detailed MDR procedure for our client’s competitor
Client Impact
The client was able to make updates to their device design and User Direction and Package Insert
The client was able to benchmark their MDR procedure and make specific process adjustments/ improve level of competitiveness
