Blue Life Solutions Achieves ISO 13485:2016 Certification, Strengthening Commitment to Medical Device Excellence | BioSpace

LAS VEGAS, Oct. 26, 2023 /PRNewswire/ — Blue Life Solutions, a pioneering contract medical device manufacturing company specializing in sample collection devices, announced the receipt of its 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.

ISO 13485 is a globally recognized standard that symbolizes an organization’s steadfast commitment to quality, regulatory compliance, and the implementation of rigorous processes to guarantee the safety and efficacy of medical devices.

“We are thrilled to announce our ISO 13485:2016 certification,” stated Tarek Soubra, General Manager of Blue Life Solutions. “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 unwavering dedication to its customers, partners, and the patients they collectively serve. This achievement solidifies the company’s position as a trusted and dependable partner in the medical device manufacturing industry. Achieving ISO 13485:2016 certification signifies Blue Life Solutions’ dedication to the following core principles:

  1. Quality Assurance: Blue Life Solutions places quality at the forefront of its operations, ensuring that its medical devices consistently meet or exceed industry standards.
  2. Regulatory Compliance: The company is committed to adhering to all regulatory requirements, ensuring that its products meet the stringent criteria set by regulatory bodies.
  3. Patient Safety: Blue Life Solutions prioritizes patient safety, designing and manufacturing medical devices with the highest levels of safety in mind.
  4. Process Excellence: The ISO 13485:2016 certification attests to Blue Life Solutions’ implementation of robust processes, ensuring the reliability and consistency of its products.

For more information about Blue Life Solutions, please visit

About Blue Life Solutions:

Blue Life Solutions is a pioneering contract medical device manufacturing company dedicated to enhancing accessibility, optimizing workflows, and dismantling healthcare barriers with the mission to facilitate life-saving diseases diagnoses. Their specialization lies in DNA/RNA sample collection devices and In Vitro Diagnostic Devices. They offer 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.

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SOURCE Blue Life Solutions