Tools & Services

Quick Link: ISO 13485: 2016 | MDSAP | MDR | Regulatory Intelligence |

ISO 13485: 2016

ProductPrice (Swiss Franc)
ISO 13485:2016 Checklist29.- CHF

EU AI Act Gap-Assessment Tool

ProductPrice (Swiss Franc)
EU AI Act Gap-Assessment Tool299.- CHF

QMSR Gap-Assessment Tool

ProductPrice (Swiss Franc)
QMSR Gap-Assessment Tool499.- CHF

MedDO / MepV SR 812.213

ProductPrice (Swiss Franc)
MedDO / MepV Assessment Tool199.- CHF

MDSAP

ProductPrice (Swiss Franc)
MDSAP vs. ISO 13485:2016 Checklist299.- CHF

MDR

ProductPrice (Swiss Franc)
PMCF-Plan0.- CHF
Classification49.- CHF
Economic Operators Checklist99.- CHF
MDR Gap-Assessment Tool780.- CHF
General Safety and Performance Checklist99.- CHF
MDR Gap-Assessment Tool incl. ISO 13485: 20161’380.- CHF
MDD vs MDR Gap-Assessment Tool1’090.- CHF

IVDR

ProductPrice (Swiss Franc)
IVDR Gap-Assessment780.- CHF
IVDR Gap-Assessment incl. ISO 13485:20161’380.- CHF
IVDD vs IVDR Gap-Assessment1’090.- CHF
MDR vs IVDR comparison table29.- CHF

REGULATORY INTELLIGENCE

ProductPrice (Swiss Franc)
Paper (12 Editions)890.- CHF

Elly-Regulatory Affairs Assistant

ProductPrice (Swiss Franc)
Elly-Regulatory Affairs Assistant948.- CHF