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Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR or IVDD Notified Body, UKCA MD Approved Body or MDSAP Customers.
  • Guide

Preparing For Your Product Safety Certification Evaluation

The typical product safety certification product evaluation process

Man looking at test instrument

Although individual projects vary, the typical product evaluation process for a product safety certification has a number of steps for both you and UL Solutions, and follows the path below:

Certification product evaluation process flow chart

Some certifications may require other evaluation such as initial lot inspection at production site for Japan S Mark and retesting at local testing laboratory for Argentina S Mark before a customer is authorized to ship products with a certification mark.

inspection and surveillance flow chart
  • Note 1: Typically safety and/or EMC tests are required. Other tests may be required, depending on certificates.
  • Note 2: Inspection is required only for some types of certificates, e.g., CB Certification does not require inspection. When conducting inspections, CENELEC CIG inspection procedure is typically used.