Michael Barbella, Managing Editor01.18.24
Blue Life Solutions has achieved ISO 13485:2016 certification. This achievement underscores the company's dedication to upholding the highest standards of quality, and ISO 13485:2016 certification serves as a pivotal milestone in Blue Life Solutions' mission to advance life-saving disease diagnostics, according to the Las Vegas-based firm.
ISO 13485 is a globally recognized standard that symbolizes an organization's commitment to quality, regulatory compliance, and the implementation of rigorous processes to guarantee medical device safety and efficacy.
"We are thrilled to announce our ISO 13485:2016 certification," Blue Life Solutions General Manager Tarek Soubra stated. "This milestone represents the culmination of our team's hard work and dedication to ensuring the utmost quality in our medical devices. It reaffirms our commitment to not only meeting but exceeding the expectations of healthcare providers and the patients they serve."
Blue Life Solutions' ISO 13485:2016 certification is a testament to the company's dedication to its customers, partners, and the patients they collectively serve. Achieving ISO 13485:2016 certification signifies Blue Life Solutions' dedication to quality assurance, regulatory compliance, patient safety, and process excellence.
Blue Life Solutions is a contract medical device manufacturing company dedicated to enhancing accessibility, optimizing workflows, and dismantling healthcare barriers with the mission to facilitate life-saving diseases diagnoses. It specializes in DNA/RNA sample collection devices and in-vitro diagnostic devices. The firm offers automated reagent dispensing, custom packaging, labeling, and fulfillment services. Blue Life Solutions is a registered FDA facility, ISO 13485:2016 certified, and adheres to US 21 CFR Part 820 (cGMP) regulations.
ISO 13485 is a globally recognized standard that symbolizes an organization's commitment to quality, regulatory compliance, and the implementation of rigorous processes to guarantee medical device safety and efficacy.
"We are thrilled to announce our ISO 13485:2016 certification," Blue Life Solutions General Manager Tarek Soubra stated. "This milestone represents the culmination of our team's hard work and dedication to ensuring the utmost quality in our medical devices. It reaffirms our commitment to not only meeting but exceeding the expectations of healthcare providers and the patients they serve."
Blue Life Solutions' ISO 13485:2016 certification is a testament to the company's dedication to its customers, partners, and the patients they collectively serve. Achieving ISO 13485:2016 certification signifies Blue Life Solutions' dedication to quality assurance, regulatory compliance, patient safety, and process excellence.
Blue Life Solutions is a contract medical device manufacturing company dedicated to enhancing accessibility, optimizing workflows, and dismantling healthcare barriers with the mission to facilitate life-saving diseases diagnoses. It specializes in DNA/RNA sample collection devices and in-vitro diagnostic devices. The firm offers automated reagent dispensing, custom packaging, labeling, and fulfillment services. Blue Life Solutions is a registered FDA facility, ISO 13485:2016 certified, and adheres to US 21 CFR Part 820 (cGMP) regulations.