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Due-diligence and technical analysis
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Assistance with IP (patent) file preparation and submission
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Technical feasibility studies
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Design Input file preparation
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User Needs Document
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Design and Development Plan
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System Level Requirements
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Hazard and Background Checklist
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Project Plan preparation and Project Management throughout the life of the projects
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Risk File preparation and management throughout the life of the projects, as required per ISO 14971, including:
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FMEA
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Risk Management plan
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RISK ANALYSIS
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Manufacturing Plan Development
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Quality Plan Development
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Set up of DHF, DMR and other records and reports
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SOP development/reviews
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Forms development
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Assistance with Sterilization Validations
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Assistance with material’s biocompatibility validation
