We Are Now ISO 13485:2016 and ISO 45001:2018 Certified!

We are proud to announce that we have been awarded ISO 13485:2016 and ISO 45001:2018 certifications from SOCOTEC Certification International. These certifications indicate that our quality management system maintains stringent international standards for medical devices, including in vitro diagnostic assays.

To be certified ISO 13485 and ISO 45001, our materials, processes, products and services underwent rigorous and independent testing for safety, product performance or reliability. Specifically, the scope of the certifications covers:

  • Manufacturing and distribution of buffers and molecular diagnostic reagents for the use in in vitro diagnostic medical devices
  • Provision of standard and customised services for:
    • DNA Sanger Sequencing
    • Fragment Analysis
    • Next-Generation Sequencing and
    • Other molecular biology services for in vitro diagnostic medical devices
  • Sales, distribution, machine commissioning/maintenance and manufacturing of 1st BASE's products including:
    • DNA Sequencing Services
    • Fragment Analysis Services
    • Peptide Synthesis
    • Antibody Production
    • Protemics Services
    • Biochemical and Ready to use Buffers and Molecular Biology Services

To view certification, please download from below: