UL provides medical device manufacturers with a complete offering of third-party regulatory approvals, product testing and certification, usability testing.

Specific offerings pertaining to regulatory requirements for global approvals include:

Regulatory

  • Brazil: INMETRO certification and testingEU: RoHS II compliance services for medical device and laboratory equipment submissions
  • Canada: ISO 13485 certification under the CMDCAS program
  • Europe: Notified Body and CE Marking for In Vitro Diagnostic Directive (IVDD) and IVDR and Medical Devices Directive (MDD) and MDR
  • India:  ICMED
  • Japan: JIS testing and evaluation
  • MDSAP:  Medical Device Single Audit Program
  • Taiwan Technical Cooperation Program for European Manufacturers

Testing, Evaluation and Certification

Compliance and Training

  • RoHS II directive training
  • On-site standards training workshops and public seminars
  • International certification training workshops

UL LLC., recognizes and respects the need to maintain impartiality through separation of its services.  If an organization is certified with UL Medical & Regulatory Service to a management system, UL Medical solutions will not provide consultancy services for that particular management system and Notified Body for IVD and MDD.

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