Our Services

EnPak LLC designs services to meet the evolving needs of the MedTech industry. In addition, we provide consulting services and flexible logistics support for medical device manufacturers and suppliers of all sizes. Whether you’re an established OEM, CMO, or an emerging startup, we help you navigate complex regulatory and operational challenges. Notably, we do so without the restriction of minimum volume requirements.

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

Some typical projects we support:

• Contract Manufacturers – Cleaning, packaging, and labeling
• Orthopedic Equipment Manufacturers – Recall and rework services
• MedTech Startups – Customer service, warehousing and order fulfillment

EnPak LLC has deep roots in Quality Systems, Regulatory Affairs and Labeling.  Initially, we focused on medical device recall and rework management. Over time, however, we expanded our services to support the day-to-day demands of medical device operations.

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

Medical Device Cleaning
Through a strategic partnership with Ecoclean, EnPak LLC established the Clean & Pack Technology Center – 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
EnPak LLC helps manage products throughout their lifecycle specifically with scalable support for warehousing, inventory management, order fulfillment, vendor coordination, and returns processing.

Recall and Rework Management
EnPak LLC’s recall and rework management includes over-labeling, repackaging, re-boxing, inspection, and compliant scrap disposal—ensuring that reworked inventory is processed with precision and documented to meet FDA and ISO standards.

Production Operations Support
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.