STEP 1: Initial Contact
During the initial contact you will help UL understand your needs, so UL can design a service package to get you to the market. We will go through the following questions with you:
- In which geographical areas would you sell your product in first?
- Describe the product?
- What are the products intended uses?
- What medical claims do you make about your product?
- When do you want to get to market?
- What phase are you in your product development?
- If applicable, what phase are you in your quality system development?
- How big is your firm?
- Do you want an integrate the compliance package during your product design cycle?
- Are you planning to subcontract your manufacturing?
STEP 1A: (optional)
- UL's Gap analysis services, recommended for new products and/or new clientsOn Technical files, UL will review the contents of your file as you develop it
- On QMS, UL can review your process as you implement and develop them
- UL can show you the CE conformity paths, allowing your to make an informed and sound business decision
- UL can review your device as you develop it
- UL can prepare a detailed written report of the GAP items
- UL can perform the GAP analysis on site for Technical files, Devices, and/or processes
- UL can, upon completion of the GAP analysis, review the finding(s) with your team. The review can be done onsite or within UL's facilities.
Other steps
