Underwriters Laboratories - UL

UL provides resources to support manufacturers with global regulatory approvals

UL provides comprehensive services to support global regulatory submissions

UL provides comprehensive solutions to support global regulatory approvals

UL is known for expertise, integrity and 3rd party safety testing. With UL's Health Sciences team, you also have access to all the services needed for complying with regulatory requirements around the world.

Download our brochure at http://web.ullifeandhealth.com/ul to see our full suite of services in more detail.

Solutions include:

  • 3rd party regulatory approvals: EU Notified Body, MDD, IVDD, Japan PAL, Saudi Arabia

  • Management Systems Certification: ISO 13485, CMDCAS, ISO 14971,

  • Safety testing & certifications: IEC 60601, IEC 61010, Brazil INMETRO, IECEE CB Scheme

  • Software certification: IEC 62304, IEC 60601 Clause 14

  • Health IT and Interoperability: Testing and Continua Test Lab

  • Pre-Clinical testing: Biocompatibility ISO 10993, Physical and Chemical testing, Microbiological testing

  • Ophthalmic testing

  • Packaging and Transportation testing, Shelf life testing

  • Validation of cleaning, reprocessing and sterilization

  • Human Factors Engineering & Usability:  IEC 60601-1-6, ISO 62366, HE-75

  • CRO: ISO 14155

  • EMC: IEC 60601-1-2, EMC CBTL, FCC Part 18 and 15B, IEC/EN 61326-1, IEC/EN 61326-2-6

  • Knowledge solutions, Training and more

Links and Resources:

  • View Customer Testimonials and our 2-minute video: http://web.ullifeandhealth.com/ul 

  • Previously published articles are found at: http://www.ulmedicaladvisory.com/resource-center/white-papers/

  • The Health Sciences Global Regulatory Digest back issues may be downloaded from the UL Library at www.ul.com/library

  • Find UL White Papers - www.ul.com/library

  • View our full Human Factors Engineering capabilities at www.wiklundrd.com

  • View UL’s comprehensive services for the Medical industry at www.ul.com/medical

  • Dedicated web page with resources for IEC 60601: www.ul.com/60601