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DirectoryIndustryMedical Technology IndustryWeinfeldenDoMaGe AG
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DoMaGe AG

Summary

About the company

DoMaGe AG is an independent engineering and consulting company. It advises on CE marking, validations, and quality and environmental management, and supports the practical implementation of management systems and certification processes.

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Products & services

Industry:Medical Technology IndustryWholesale - Health & Cosmetic Products
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Consulting
Consulting for the practical implementation of management systems and working methods; quality management according to DIN EN ISO 9001 and ISO 13485, external quality officers, internal and external audits, support for certification.
Conducting certification preparations
Assessment of the current state, analysis of gaps, definition of required actions, formation and training of working groups, research of statutory requirements, documentation of organization and processes.
FDA consulting
Establishment of quality management according to FDA requirements, support with product approval and registration, guidance for the preparation and execution of FDA certifications.
Technical documentation
Preparation of the required technical documentation for the company; oversight of notification obligations and the reporting and surveillance system for medical device manufacturers in line with MPG and DIMDI requirements.
Validations
Advisory support and planning as well as execution of validations of methods and processes, qualification of equipment items and involved personnel for medical device manufacturers.
Certifications
Advisory support and assistance up to certification, including accompaniment by an auditor with experience at Swiss Safety Center.
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Location

Marktstrasse 12
8570 Weinfelden

At a glance

Legal form
Corporation
UID
CHE-113.266.973
Founded
2006 · 20 years
Last commercial register change
December 13, 2021
Employees
1 to 10

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