Medical Services

UL's step-by-step regulatory process

STEP 2: Assessing Conformity (Pre-Certification)

• Assess the Technical File
• Assess the Quality Manual
• Assess the product (Review the Device for compliance to applicable standards)
• Prepare Audit agenda for your main processes
• Confirm and establish Path to conformity for CE

Other steps

• Forward to step 3
• Back to step 1
• Back to all steps