Frequently Asked Questions
EnPak LLC FAQs
If you have questions about EnPak LLC or our operations support services for medical device manufacturers, we’ve gathered answers to many frequently asked questions here. Whether you’re exploring consulting, operations support or recall management and rework services, you’ll find helpful information to guide your decisions. If you need further assistance, our team is ready and available to help.
EnPak LLC Frequently Asked Questions
Is the EnPak LLC quality management system ISO 13485:2016 Certified?
Yes, EnPak LLC maintains an FDA 21 CFR Part 820–compliant and ISO 13485:2016–certified quality management system. This ensures our team consistently meets regulatory requirements and delivers the high-quality standards our customers expect.
Is EnPak LLC FDA registered?
Yes, EnPak LLC is FDA registered under establishment number 3015119628.
Does EnPak LLC have minimum volume requirements?
No, EnPak LLC does not require minimum order volumes for our services. We support startups, small businesses, established medical device manufacturers, and contract manufacturers alike. Our team delivers the level of service you need—no matter the order size.
Can orders be sent directly to EnPak LLC as part of the management of the order fulfillment process?
Yes, you can send orders directly to EnPak LLC by email. Some customers also grant us access to their sales portals, allowing us to monitor and respond quickly to incoming requests.
How does EnPak LLC keep track of inventory?
EnPak LLC tailors inventory management to fit your needs. If you already use an inventory system, we actively manage the data directly within your platform. However, for smaller product lines, simple tools like Excel often provide an effective way to track inventory.
Does EnPak LLC have the ability to create and print labels?
Yes, EnPak LLC uses BarTender Barcode software to create and print product labels. First, we design the labels according to your specifications. Then, we submit the designs for your approval prior to using them in production.
Can EnPak LLC create UDI labels?
Yes, EnPak LLC has experience with UDI labeling.
Does EnPak LLC finish package product?
EnPak LLC works with both contract manufacturers and device manufacturers to finish package nonsterile implants and instruments.