November 2009

Underwriters’ Laboratory

R.A. Venkitachalam
Vice President & Managing
Director � UL Emerging Markets

Kalyani Platina,
3rd Floor, Block I, No. 24, EPIP Zone,
Phase II, Whitefield, Bangalore 560066
Tel: +91-80-41384400
Fax: +91-80-28413759

Start-up Year: 1894
Number of Employees: 6800 + staff
Branch/Overseas Offices:
64 laboratory, testing and certification
facilities across the world.

Company Profile

Underwriters Laboratories (UL) is an independent product safety certification organisation that has been writing standards for safety, testing products and is involved in conformity assessment since 1894. UL evaluates more than 19,000 types of products, components, materials and systems annually with 20 billion UL Marks appearing on 72,000 manufacturers’ products in the global marketplace each year. UL has also issued nearly 6,000 registrations to management system standards. UL’s worldwide family of companies and network of service providers includes 64 laboratory, testing and certification facilities serving customers with business operations on six continents.

Being one of the world’s largest Conformity Assessment Service Providers backed by more than a century of experience in product testing and inspection; UL has assessed, tested or inspected billions of products, systems and processes. A key part of UL’s mission is to foster quality assurance and improvement, whilst maintaining its reputation for professionalism and integrity. UL offers a complete bouquet of services in product and process safety and compliance. Few of the services that it offers cater to various categories such as medical equipment, renewable energy, plastics, fire protection, industrial control equipment, IT, wire and cable, power and controls and other categories, which are designed to meet the requirements of their valued customers. The services UL offers in quality management systems especially in the areas of aerospace, telecom, medical compliance, IT security and automotive standards provide cutting edge level of expertise.

Product details/Solutions

Regulatory Services

  • US FDA 510(k) review and inspection

  • SFDA services for China (CCC)

  • Europe notified body for in-vitro diagnostics (IVDD) and medical devices directives (MDD) CE marking

  • Canada ISO 13485 certification under the CMDCAS program

  • Japan JIS testing and evaluation, PAL third party certification

  • Brazil in metro registration

  • China: SFDA registration/CCC certification
  • Product Testing, Evaluation & Certification
    • Quality management system registration: ISO 13485

    • Preliminary investigation of your medical devices

    • CB test report and certificates

    • Product testing and certification to UL 60601/IEC 60601z

    • Product safety testing and certification to UL 61010/ IEC 61010

    • Conformance to medical software IEC 60601-1-4

    • EMI/EMC standards

    • Risk management certification: ISO 14971 standard

    UL Knowledge Solution

    • Gap analysis: in house customised training: public seminars
      Management system registration: ISO 13485

    • Designing for compliance to IEC 60601-1(2nd edition), IEC 60601-1 (3rd edition)

    • Understanding MDD and IVDD requirements

    • FDA (510) k requirements

    • Risk Management: ISO 13485 – awareness and internal audit
      -International certification training workshops


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