Get your
Medical Device QMS
from the Experts

Fully compliant to ISO 13485:2016

Manufacturer
Importer
Distributor

Why a Quality Management System?

  • Process implementation required by MDR 2017/745 and IVDR 2017/746
  • Market Surveillance of Products required
  • Documented Process with change control needed

The Features

Quality Manual

compliant to ISO 13485:2016

Quality Manual comes:

  • as template or tailored
  • fully configurable word-file
  • contained in the eDMS

Quality Policy

compliant to ISO 13485:2016

Quality Policy comes:

  • as template or tailored
  • fully configurable word-file
  • contained in the eDMS

SOPs

compliant to ISO 13485,  MDR/IVDR

SOPs come:

  • as template or tailored
  • fully configurable word-file
  • contained in the eDMS

Forms

compliant to ISO 13485, MDR/IVDR

Forms come:

  • as template or tailored
  • fully configurable word-file
  • alternatively: digital forms in the eDMS
  • contained in the eDMS

Tailoring

provided by Experts

Tailoring is provided:

  • based on your inputs
  • in compliance with quality policy and products
  • contained in the eDMS

Training

compliant to ISO 13485

Training comes:

  • as virtual training
  • for single person or teams
  • based on SOPs and Forms

eDMS

compliant to EU GxP, 21 CFR 11, GAMP5

eDMS comes:

  • as full access
  • fully validated
  • annual license included for the first year

Coaching

provided by Experts

Coaching is provided:

  • based on your business case
  • in compliance with quality policy and products
  • based on the SOPs

The Offer for Distributors

DIY

CHF 4'999.00

Features

  • QMS package
  • 60 SOP's and forms
  • Tailor yourself
Order
Recommended

Support

CHF 9'999.00

Features

  • QMS Package
  • 60 SOP's and forms
  • eDMS access
  • Tailored by Experts
Order

Relax

CHF 17'999.00

Features

  • QMS Package
  • 60 SOP's and forms
  • eDMS access
  • Tailored by Experts
  • Training by Experts
Order

There is a basic offer with a checklist, the Quality Manual template and Quality Policy template available upon request as well. The QMS will be provided in English and additional languages are available upon request.

The Offer for Importer

DIY

CHF 4'999.00

Features

  • QMS package
  • 60 SOP's and forms
  • Tailor yourself
Order
Recommended

Support

CHF 12'799.00

Features

  • QMS Package
  • 60 SOP's and forms
  • eDMS access
  • Tailored by Experts
Order

Relax

CHF 19'999.00

Features

  • QMS Package
  • 60 SOP's and forms
  • eDMS access
  • Tailored by Experts
  • Training by Experts
Order

There is a basic offer with a checklist, the Quality Manual template and Quality Policy template available upon request as well. The QMS will be provided in English and additional languages are available upon request.

The Offer for Manufacturer

DIY

CHF 9'999.00

Features

  • QMS package
  • 60 SOP's and forms
  • Tailor yourself
Order

Support

Please Inquire

Features

  • QMS Package
  • 60 SOP's and forms
  • eDMS access
  • Tailored by Experts
Inquire

Relax

Please Inquire

Features

  • QMS Package
  • 60 SOP's and forms
  • eDMS access
  • Tailored by Experts
  • Training by Experts
Inquire

There is a basic offer with a checklist, the Quality Manual template and Quality Policy template available upon request as well. The QMS will be provided in English and additional languages are available upon request.