REGULATORY SERVICES
Creating a Comprehensive Regulatory Plan
A comprehensive regulatory plan involves addressing many elements ranging from the relatively simple to the complex.
A comprehensive regulatory plan should address:
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Intended use and indications for the product
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Key product claims and how they will be supported
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Possible predicate devices/products
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Country specific regulatory pathways
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Product classification in targeted countries
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Labeling requirements
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Pertinent regulatory guidance documents
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Standards and directives
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Biocompatibility testing
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Preclinical studies
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Clinical studies
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Manufacturing sites
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Export requirements and/or conditions
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Possible regulatory risks
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Contingency plans
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