Tutela Medical supply and install fully validated and MHRA compliant web-based, wireless temperature monitoring and recording systems for all types of Medical, Biotech, Laboratory, Pharmacy, Hospitals, Tissue Banks, Blood Banks, and Research facilities worldwide.
Through our rigorous data security protocols, including mirrored servers, our customers enjoy unprecedented data security, access and control of their monitoring processes. The Tutela Genesis 3 interface is compliant with regulatory bodies and medical associations including MHRA, NHS Digital, UKAS, CQC, HTA and FDA.
Tutela Monitoring Systems are certified to ISO9001:2015 Fully meeting the exacting requirements of the FDA CFR 21 part 11.
Tutela is HSCN (N3) compliant. Our IT servers and databases are regulated and managed through the Company’s ISO9001:2015 quality management system and is data security compliant to ISO27001.
Tutela’s UKAS Certificate of Accreditation to the ISO17025 can be found on the website.
Under the ISO17025 standard, accredited businesses such as Tutela undergo ongoing internal and external audits overseen by UKAS, which examine procedures, competencies and good practice in order to maintain the UKAS Accreditation.
UKAS is the national accreditation body for the United Kingdom, appointed by government, to assess organisations that provide certification, testing, inspection and calibration services.
Tutela are also certified for multi-point callibration. Multi-point calibrations are undertaken when customers have time and temperature sensitive products requiring enhanced calibration in order to meet strict regulatory compliance standards. This is especially relevant for the temperature controlled storage of vaccines, blood, plasma and tissue inventories.