Documentation Kits
ISO 13485 Compliance Kit
Complete set of SOPs / templates for compliance with ISO 13485:2016
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25 SOPs
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> 30 Templates
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Full Support by email and possibility to ask for a video call
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Free Updates in case any regulatory requirements will change
299 €
ISO 42001 Compliance Kit
All what you need for your Artificial Intelligence Management System
299 €
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8 SOPs fully aligned with ISO 42001:2023
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10 Templates complex integrated into the related SOPs
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Full Support by Email
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Free Document Updates
ISO 27001 Compliance Kit
Full set of SOPs and templates for compliance with ISO 27001:2022
399 €
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23 SOPs
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More than 60 templates integrated into the relevant SOPs
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Full Support by Email
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Free Updates in case any regulatory requirements will change
Cybersecurity Kit
Set of documents to boost your compliance with FDA and EU MDR Cybersecurity Requirements for Medical Devices
299 €
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5 SOPs / plans fully aligned with FDA cybersecurity guidance and EU MDCG guidance
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Full Support by email and possibility to ask for a video call
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Free Updates in case any regulatory requirements will change
EU MDR Kit
Everything you need to have to be compliant with EU MDR 2017/745 Requirements
199€
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20 documents between SOPs, templates and Checklists, aligned with MDCG requirements
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Full Support by email and possibility to ask for a video call
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Free Updates in case any regulatory requirements will change
MDSAP Documentation Kit
Kit of 10 SOPs to ensure fully compliance to MDSAP requirements
359€
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5 SOP focused on market access in MDSAP countries
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5 SOP focused on Vigilane requirements in MDSAP countries
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Full Support by email and possibility to ask for a video call
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Free Updates in case any regulatory requirements will change
