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DirectoryBusiness & Technical ServicesTechnical Consulting & EngineeringMerlischachenINGENIEURDIENSTLEISTUNG Christian Schumann GmbH
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INGENIEURDIENSTLEISTUNG Christian Schumann GmbH

Summary

About the company

INGENIEURDIENSTLEISTUNG Christian Schumann GmbH provides technical and quality-related services for the medical device sector, including validation and qualification (DQ, IQ, OQ, PQ), internal and external audits, and quality management system support. The company also offers CAPA implementation, risk management according to EN ISO 14971, and general technical support such as project management, production technologies and design-to-production transfer.

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Products & services

Industry:Technical Consulting & Engineering
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Mechanical Engineering Industry
Medical Technology Industry
✓ Offered8
Validation and Qualification
Creation of validation plans, user requirements and technical specifications; support for design, installation, operational and performance qualifications according to EN ISO 13485 and 21 CFR 820.
Quality management systems
Set-up and further development of quality management (QM) systems, process support for regulatory requirements, and documentation according to EN ISO 13485 and GDP requirements.
Audits
Conduct internal and external process audits to verify compliance with EN ISO 13485, as well as independent review of internal work processes.
CAPA management
Creation, implementation and assessment of corrective and preventive actions; support for introducing a CAPA system and for integrating it into existing QM systems.
Risk management
Support with risk analyses according to EN ISO 14971, as well as development and integration of risk management into existing quality management systems.

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Location

Luzernerstrasse 212
6402 Merlischachen

At a glance

Legal form
Limited Liability Company
UID
CHE-386.354.522
Founded
2019 · 7 years
Last commercial register change
July 4, 2019
Employees
1 to 10

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