FPO Case Study TItle

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Challenge

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A client required a clinical and regulatory department to be built to support their 510k submission. 

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Solution

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• Arete provided a temporary full-time Clinical and Regulatory Lead acting as the interim Director of both departments.
• Arete hired team members to fill out these organizations and build up the requisite process and systems to maintain the team.

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Outcome

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• The company was left with a clinical and regulatory team.
• The product went through clinicals and obtained regulatory clearance.

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Key metrics

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• Product clearance.
• A high-quality team.

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