Our Services

Not every operational need makes sense to handle in-house. You may need extra hands for a time-sensitive project. You may also need help with work outside your team’s usual responsibilities.  Finally, you may just need support for a temporary increase in workload.

That’s where EnPak LLC comes in.  We provide flexible support for MedTech and Life Science companies.  Specifically, services range from consulting and specialized projects to kit management, logistics, cleaning, and recall management.  Whether you’re an established OEM, CMO, or an emerging startup, we help you navigate complex regulatory and operational challenges. In addition, we do so without the restriction of minimum volume requirements.

From product launch through daily operations, we support companies at every stage of growth. As a result, our customers stay focused on innovation.

For example, here are a few ways we can help:

Contract Manufacturers (CMOs) – Cleaning, packaging, and labeling

Original Equipment Manufacturers (OEMs) – Recall and rework services

Startups – Customer service, warehousing and order fulfillment

EnPak LLC has deep roots in Quality Systems, Regulatory Affairs and Labeling.  While we initially focused on medical device recall and rework management, this evolved based on customer need. As a result, we expanded our services to support the day-to-day demands of medical device operations. Today, we help companies manage the full range of those needs.

Consulting & Specialized Services
EnPak LLC delivers consulting and specialized services that cover medical device cleaning, document legalization, regulatory affairs, quality management systems, and project management.

Medical Device Cleaning
For cleaning needs, EnPak LLC established the Clean & Pack Technology Center through a strategic partnership with Ecoclean. This center is a one-stop solution for parts cleaning processes, contract cleaning, and downstream services.

Kit Management
EnPak LLC’s comprehensive kitting solutions include not only kit creation, but also replenishment, decontamination and inspection.

Medical Device Logistics
Once products are ready to move, EnPak LLC helps manage them throughout their lifecycle. Specifically, this includes scalable support for warehousing, inventory management, order fulfillment, vendor coordination, and returns processing.

Recall Management
When issues arise, EnPak LLC’s recall management and rework services include over-labeling, repackaging, re-boxing, inspection, and compliant scrap disposal. As a result, reworked inventory is processed with precision and documented to meet FDA and ISO standards.

Operations Support
Finally, from inspection to non-sterile packaging to labeling, EnPak LLC’s operations support services help ensure product integrity and compliance.

With over 60 years of combined industry experience, the EnPak LLC team understands the regulatory pressures, time constraints, and resource challenges that MedTech companies face. Not only is our Quality Management System FDA 21 CFR Part 820 compliant, but also ISO 13485:2016 certified.  This ensures that every service we deliver meets the highest standards of quality and conformance. Read our Quality Commitment.