Technical File

  • EU MDR Technical Documentation Kit

    EU MDR Technical Documentation Kit

    €429.00

    The complete Annex II technical file for EU MDR (Regulation 2017/745) in one coordinated set. Eight professionally drafted Word templates from Device Description to Declaration of Conformity, with Team-NB position papers integrated. Ready for Notified Body submission.

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  • MDR Complete Bundle

    MDR Complete Bundle

    €999.00

    The complete EU MDR documentation set in one premium bundle. Three coordinated kits covering technical file, clinical evaluation and risk management. 22 templates total. Save 15% vs buying separately.

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