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Quality Management

Our management system is continually monitored and improved, and is subject to regular internal audit by trained management system auditors as well as independent external audits by certification and accreditation bodies.

Medical Device Single Audit Program (MDSAP) Certification

MDSAP logo

Developed by the International Medical Device Regulators Forum (IMDRF), the MDSAP enables medical device manufacturers to fulfil the requirements of multiple participating regulatory authorities through a single QMS audit.

The certification from Lloyd’s Register (LR) is for the full MDSAP audit criteria, which is based on ISO 13485:2016 with additional country-specific requirements for the US FDA, Health Canada, TGA (Australia), ANVISA (Brazil), MHLW and PMDA (Japan).

The scope of the approval is applicable to the design, development and manufacture of DNA FISH probes, ancillary products and in vitro diagnostic kits and reagents for the detection of chromosomal abnormalities in life science research and diagnostic use.

View MDSAP certification >

ISO 9001:2015 and ISO 13485:2016 Certification

ISO 9001 2015 and ISO 13485 combined large spacing

Certified by Lloyd’s Register since October 1999, the ISO 9001 and ISO 13485 certification of our Management System demonstrates Cytocell's commitment to the delivery of products and services of the highest quality.

For this management system certification the scope of the approval is applicable to the design, development and manufacture of DNA FISH probes, ancillary products and in vitro diagnostic kits and reagents for the detection of chromosomal abnormalities in life science research and diagnostic use.

View ISO 9001:2015 certification >

View ISO 13485:2016 certification >

Oxford Gene Technology Quality Management

Cytocell Ltd. is a subsidiary of Oxford Gene Technology (OGT). To view information about OGT’s quality management system please visit the OGT website.