Quality & Regulatory

QUALITY POLICY

As a supplier of medical devices, our policy is to provide solutions that are safe and effective.  As part of developing, manufacturing and marketing solutions to healthcare providers and their patients, our policy is to follow strict quality controls and implement a quality management system and processes to meet regulatory and clinical standards, and satisfy the requirements of our customers.

QUALITY MANAGEMENT SYSTEM

Tiba Medical’s quality management system is built upon the international standard EN/ISO 13485:2003 along with the United States Food & Drug Administrations (FDA) Quality System Regulation (QSR) 21 CFR 820, the European Medical Device Directive (MDD), Council Directive 93/42/EEC and the Canadian Medical Device Regulation (CMDR), SOR/98-282.  Tiba Medical is a registered establishment with the US FDA and fully compliant with its Good Manufacturing Practices including 21 CFR Part 820, the Quality Systems Regulations.

ISO13485:2003 Quality System Certification

US FDA Establishment Registration

GLOBAL REGULATORY REPRESENTATIVES


Our in-country representatives for regulatory affairs issues and incident reporting are as follows:

EUROPE - Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570
Web:  www.EmergoGroup.com

NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY

Tiba Medical maintains ISO 13485:2003 certification and is annualy audited by the following third party:


DQS GmbH
Deutsche Gesellschaft zur Zertifizierung von Managementsystemen
Postfach 50 07 54, 60395 Frankfurt am Main, GERMANY
Tel.: +49 (69) 9 54 27 -0
Fax: +49 (69) 9 54 27 -1 11
Web:  www.dqscert.com

 

 

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