Frequently Asked Questions
Can orders be sent directly to EnPak as part of the management of the order fulfillment process?
Yes, orders can be sent directly to EnPak via email. Several of our customers give us access to their sales portal so we have visibility to the requests.
How does EnPak keep track of inventory?
It’s dependent on customer needs. If you have an inventory management system, we manage the data directly in that system. If you only have a few products it may be sufficient to manage the inventory using basic tools like Excel.
Are their minimum volume requirements?
No, we do not have minimum volume requirements for our services. We are here to support small businesses, and want to make sure you get the help you need.
Does EnPak have the ability to create and print labels?
Yes, we use the BarTender Barcode software to create and print product labels. We design the labels per your specifications and obtain your approval prior to using them in production.
Does EnPak finish package product?
EnPak works with both contract manufacturers and device manufacturers to finish package nonsterile implants and instruments.
Can you create UDI labels?
Yes, we have experience with UDI labeling.
Is EnPak FDA registered?
Yes, the EnPak establishment registration number is 3015119628.
Is the EnPak quality system ISO 13485 Certified?
The EnPak quality management system is not ISO 13485 certified. However, the EnPak quality management system is 21 CFR Part 820 and ISO 13485:2016 compliant.
Why is it important that EnPak is Disadvantaged Business Enterprise (DBE) certified?
Companies awarded federal government contracts are required to spend a certain % of dollars with a DBE Certified Business.