Regulatory strategy (initial FDA contacts, pre-IDE submissions, predicate device research)
Regulatory submissions: US FDA, EU, Canada, Rest of World (RoW)
Services
Regulatory:
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Regulatory strategy (initial FDA contacts, pre-IDE submissions, predicate device research) |
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Regulatory submissions: US FDA, EU, Canada, Rest of World (RoW) |
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Labeling development and/or review |
Quality Systems/Compliance:
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Quality System definition and implementation |
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Compliance audits |
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Compliance communications: Responses to 483s and Warning Letters, Field Actions (recalls, market withdrawals, field corrections), MDR/Adverse Event reporting | |
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Training: develop training materials, coordinate/deliver employee training sessions |
Design Control:
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Develop/review/audit Design History Files, Technical Files, Design Dossiers |
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Testing coordination: Electrical safety, biocompatibility, shipping/packaging |
Clinical Studies:
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Clinical protocol development and/or review |
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IRB submissions |