EnPak LLC Achieves ISO 13485:2016 Certification
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ISO 13485:2016 Certification Reinforces EnPak’s Commitment to Quality Standards
EnPak LLC, an established provider of logistics and operations services for the medical device industry, has achieved ISO 13485:2016 certification. This milestone further demonstrates that EnPak’s quality management system aligns with the latest regulatory standards for the medical device sector.
ISO 13485:2016 is a globally recognized standard for quality management systems in the medical device industry. To earn this certification, EnPak successfully completed a third-party audit of its quality system. Eagle Registrations Inc. conducted the audit and issued the official Certificate of Registration.
“Certification to ISO 13485:2016 underscores our dedication to providing exceptional services to our MedTech partners,” said Marlene Mulero-Betances, Founder and President of EnPak LLC. “It validates our commitment to the highest standards of quality, compliance, and reliability throughout the medical device supply chain.”
In addition to ISO 13485:2016 certification, EnPak LLC is FDA-registered. Our quality management system also meets FDA 21 CFR Part 820 requirements.
About EnPak LLC
Founded in 2011, EnPak LLC supports MedTech companies of all sizes by delivering consulting, logistics, and operational services. We help bring products to market quickly and efficiently. With no minimums, we provide cost-effective solutions and fast turnaround times.
To expand our capabilities, EnPak partnered with Ecoclean to create a new center focused on cleaning and packaging services. Together, we deliver advanced pre-cleaning, final cleaning, and contract cleaning solutions for medical device manufacturing operations.
Located in Warsaw, Indiana—the “Orthopedic Capital of the World®”—EnPak operates at the heart of medical technology and innovation. We prioritize quality and a people-first approach, strengthening our commitment to support medical device companies at every stage.
For more information about EnPak, visit our services page.
