Some regulatory bodies designate third parties to provide approvals for specific types of products before they are allowed to be sold and/or used in the specific regulator's area of responsibility.
UL provides the health sciences industries with end-to-end regulatory and certification services for global markets, including:
Japan: As a Recognized Certification Body under the Japan PAL third-party program, UL can provide regulatory approvals of qualified devices. And UL-qualified auditors can integrate the Japan Quality requirements into your ISO 13485 audit, saving your customers time and resources.
Europe: Work with local Notified Body auditors -- a Notified Body is an accredited organization recognized by the European Union to audit quality systems and test devices to applicable standards and directives -- to gain an objective and impartial assessment of your quality management system and technical file(s), by using UL as your Notified Body.