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Regulatory Knowledge at a Glance

Regulatory Management

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“An investment in knowledge always pays the best interest.”

Benjamin Franklin

Democratizing MedTech Regulatory Knowledge

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  • Template – Product Qualification and Classification under the EU IVDR 2017/746 (v.1.0)

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  • Checklist – ISO 13485 2016 Internal Audit (v.1.0)

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  • Template – SOP Master Validation Test Plan (v.1.0)

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  • Template – Technical Documentation Table of Content according to the IVDR (v1.0)

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  • Template – SOP Technical Documentation according the IVDR (v1.0)

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The IVD Product Types: RUO, IUO, GPR, ASR

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Claims under the MDR and the IVDR (Art. 7/7)

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The Investigational Device Exemption (IDE)

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Conformity Assessment Options for Products Failing under the MDR

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Beyond the MDR and the IVDR: The WEEE Directive, the RoHS2 Directive, the REACH Regulation and other requirements

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Trend Reporting under the MDR and IVDR (Art. 88/83)

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