MDR Technical Documentation
Design Controls
Design Controls Procedure
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Planning
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Design Validation and Transfer
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Design Transfer
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Commercialization
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Technical Remediation
Material Assessment
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External Standards List Evaluation*
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*Note: If harmonized standard does not apply, Consider if Justification is necessary
Marketing Specification
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Labeling Review
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Claims Review
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Product Specification
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Summary of Safety and Performance
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Risk Management
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Labeling
UDI-DI / Basic UDI-DI
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Implant Cards
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Process Outputs
Procedures
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Work Instructions
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Templates / Forms
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Supporting Documentation
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