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Compliance Services
Research Library
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TUV SUD America Inc.
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Achieving success in global markets requires gaining rapid market entry for your Medical Device products. The Medical Health Services Unit of TÜV SÜD America offers a variety of global compliance servic- es that help ensure your products' accept- ance and success.
Medical and In-Vitro Diagnostics TÜV Product Service is the world's leading EU Notified Body, Medical Device Compliance Testing and ...
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MSDS Writer
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In this world of interconnected glo- bal economies, companies must be aware of the regulations affecting the chemical industry, if they want to be successful and be ahead of the com- petition.
Nowhere is this adage truer than in the area of chemical hazard com- munication.
The purpose of hazard communica- tion (or HAZCOM, as it is known in the business) is to make employees in the workplace ...
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TUV SUD America Inc.
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The voluntary certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products in the global market.
In the European Union, the fulfillment of EU Directives (e.g., Active Implantable Medical Device Directive, Medical Device Directive and In Vitro Diagnostic Directive) ...
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TUV SUD America Inc.
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FDA Accredited Persons Third-Party Inspection Program (TPI) To ensure that appropriate medical device manufacturing conditions and controls are in place, the U.S. Food, Drug and Cosmetic Act established a requirement that the FDA inspect manufacturers of Class II and III Medical Devices at least once every two years. Due to limited resources and significant growth of the Medical Device Industry, ...
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TUV SUD America Inc.
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On March 21, 2010, the EC Directive 2007/47/EC will become effective. This Directive will have a big impact on the Directives 90/385/EEC and 93/42/EEC. All manufacturers declaring conformity of their products to either of these EC Directives should be aware of the following: Medical devices according to 90/385/EEC or 93/42/EEC must also comply with the new EC Directive starting March 21, 2010 , ...
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