Tools & Services

ISO 13485: 2016

Product Price (Swiss Franc)
ISO 13485:2016 Checklist 29,- CHF

MedDO / MepV SR 812.213

Product Price (Swiss Franc)
MedDO / MepV Assessment Tool 199,- CHF

MDSAP

Product Price (Swiss Franc)
MDSAP vs. ISO 13485:2016 Checklist 299,- CHF
Labeling Tool 299,- CHF

MDR

Product Price (Swiss Franc)
PMCF-Plan 0,- CHF
Classification 49,- CHF
Economic Operators Checklist 99,- CHF
MDR Gap-Assessment Tool 780,- CHF
General Safety and Performance Checklist 99,- CHF
MDR Gap-Assessment Tool incl. ISO 13485: 2016 1’380,- CHF
MDD vs MDR Gap-Assessment Tool 1’090,- CHF

IVDR

Product Price (Swiss Franc)
IVDR Gap-Assessment 780,- CHF
IVDR Gap-Assessment incl. ISO 13485:2016 1’380,- CHF
IVDD vs IVDR Gap-Assessment 1’090,- CHF
MDR vs IVDR comparison table 29,- CHF

REGULATORY INTELLIGENCE

Product Price (Swiss Franc)
Paper (12 Editions) 590,- CHF

MDR STARTING PACKAGE – INCL. REGULATORY GLOBE SUPPORT

Product Price (Swiss Franc)
This offer includes:

  • Access to several MDR tools (see below)
  • Individual Tool instruction (via. Webex or Skype)
  • Individual assessment plan (Based on your products)
  • 5 hours starting support with tips and tricks (via. Skype)
  • Regulatory Intelligence Paper (for 1 Year)

(Note: We do not prepare the assessment for you. We just support you in the first steps.)

  • 3’900,- CHF

IVDR STARTING PACKAGE – INCL. REGULATORY GLOBE SUPPORT

Product Price (Swiss Franc)
This offer includes:

  • You will get our IVDR Gap-Assessment Tool
  • Individual Tool instruction (via. Webex or Skype)
  • Individual assessment plan (Based on your products)
  • 5 hours starting support with tips and tricks (via. Skype)
  • Regulatory Intelligence Paper (for 1 Year)

(Note: We do not prepare the assessment for you. We just support you in the first steps.)

  • 3’600,- CHF