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EnPak’s quality system is now ISO 13485:2016 certified. This certification confirms that the company’s quality management system complies with the latest regulatory standards for the medical device industry.
EnPak helps medtech companies bring their products to market with consulting, logistics services and operational support. The company is partnered with Ecoclean with a center for cleaning and packaging services.
“Certification to ISO 13485:2016 underscores our dedication to providing exceptional services to our MedTech partners,” said Marlene Mulero-Betances, President and CEO of EnPak LLC. “It validates our commitment to ensuring the highest standards of quality, compliance and reliability throughout the medical device supply chain.”
In addition to ISO 13485:2016 certification, EnPak is registered with FDA and the quality management system meets FDA 21 CFR Part 820 requirements.
Source: EnPak LLC
