It is our responsibility to verify compliance to respective safety/quality standards by performing inspections, tests and audits. As our customers achieve compliance, we are able to issue a number of domestic and internationally recognized certifications.

These certifications can cover both legal and market driven requirements. The CE Marking covers the European legal requirements for the sale of product within the European Union.  Our parent company holds all the accreditations needed to test and verify that the requirements established by these European directives are met. By applying the CE Marking to your product, you demonstrate that the requirements have been fulfilled. For example, if you are a manufacturer of infusion sets (CE Medical Device Directive), or you have a drilling machine (CE Machinery Directive), or you have questions about which Directive is applicable to your product, TUV USA together with the TUV NORD Group will meet your needs. Whatever the product or standard, we as an independent certification body, can help you on the global path.

TUV USA verifies compliance through routine audits.  The TGA (German Accreditation Body) and German/European government ensure that our technical staff has the appropriate training and experience needed to deliver value driven service for your specific industry.
 

Medical Devices Division

CE, STANDARDS AND MARKING SERVICES
The European Community's mandatory CE Mark is achieved by passing safety and EC testing, conforming to the standards of your specific device classification and certifying your quality system. As part of the TUV NORD GROUP'S family of companies, we are your single source for all your CE Marking services. We are subcontracted by TUV USA to perform these services.

We provide certification for MDD, AIMDD and IVDD.
 93/42/EEC Medical Device Directive (MDD).
 90/385/EEC EC Active Implantable Device Directive (AIMDD).
 98/79/EEC In Vitro Diagnostics Directive (IVDD)/Product safety.
 EN 13485

INTERNATIONAL TESTING/VALIDATION
TUV USA only offers verification and compliance to harmonized standards for medical devices and laboratory equipment, components, subassemblies and disposables.

Implantable and disposable products include:
  Sterilization
  Validations
  Packaging Validations
  Biocompatibility Evaluation And Testing
  Clinical Evaluations

Safety Testing and Certification for the following International and European harmonized standards:
  CE marking for Medical Device Directive 93/42/EEC (MDD)
  Low voltage Directive 73/23/EEC (LVD)
  Machinery Directive 98/37/EC (MD)
  IEC/EN60601-1 Medical Electrical Equipment, General Requirements for Safety
  IEC/EN60601-2-XX series of standards for Medical electrical equipment particular requirements 
  IEC/EN61010-1 Electrical equipment for measurement, control and laboratory use,
    General Requirements for Safety
  IEC/EN60950-1 Information Technology Equipment, General Requirements for Safety
  IEC/EN60335-1 Safety of household and similar electrical appliances
  IEC/EN60335-2-XX series of standards for household and similar electrical appliances particular
    requirements
  IEC/EN60065  Safety requirements for mains-operated electronic and related apparatus for household
    and similar general use.
  IEC/EN60825-1 Safety of laser products
  IEC/EN60204-1 Safety of machinery
  Electromagnetic compatibility (EMC) testing services provided by NVLAP accredited EMC test lab
    (subcontractor)
  CE marking for EMC Directive 89/336/EEC
  IEC/EN60601-1-2 Medical Electrical Equipment, EMC requirements
  IEC/EN61326-1 Electrical equipment for measurement, control and laboratory use, EMC requirements
  EN55011/EN55022 (CISPR11/22)  Electromagnetic Emissions measurements
    (conducted and radiated emissions)
  IEC61000-4-2, ESD immunity
  IEC61000-4-3, RF immunity
  IEC61000-4-4, EFT/burst immunity
  IEC61000-4-5, Surge immunity
  IEC61000-4-6, Conducted immunity
  IEC61000-4-8, Power frequency/magnetic field immunity
  IEC61000-4-11, Voltage dips and interruptions
  IEC61000-3-2, AC mains harmonics
  IEC61000-3-3, AC mains flicker


Quality Systems Division

TUV USA Inc. offers pre-audits, initial registration audits and on going surveillance audits either semi-annually or annually for the following services which are fully accredited by TGA:

  ISO 9001:2000 Quality Management systems process approach standard.
  ISO 14001:2004 The Environmental management systems standard.
  TS 16949
  AS9100B This is the Aerospace quality management system standard that has been generated by the
     Prime Original Equipment Manufacturers of the aerospace industry.
 

In addition, TUV USA, Inc. has begun the process to expand our Aerospace accredited program to include AS9110 quality management systems for authorized repair and maintenance stations.