Get your
Medical Device QMS
from the Experts
Fully compliant to ISO 13485:2016
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
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
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
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.