Our Services
Supporting MedTech Innovation with Scalable Expertise - EnPak LLC Services
EnPak LLC’s Services are designed to support the ever-evolving needs of the MedTech industry. 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. All without the restriction of minimum volume requirements.
From product launches to operational support, EnPak LLC delivers the expertise MedTech companies need to stay efficient and focused on innovation.
Founded with deep roots in Quality Systems, Regulatory Affairs and Labeling, EnPak LLC began focused on medical device recall and rework management. Since then, we’ve expanded to offer a broad range of services tailored to the day-to-day demands of medical device operations.
Our Services Include:
Consulting
EnPak LLC offers practical, experienced guidance on device cleaning, validation, document legalization, regulatory affairs, quality management systems, and project management.
Medical Device Cleaning (Coming Soon!)
Through a strategic partnership with Ecoclean, EnPak LLC will soon be expanding its capabilities to include contract cleaning 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.
