Committed to Quality

Sentec is committed every day to patient care and safety and enhancing customer satisfaction through continual improvement of our products, services, and quality management system.

Committed to Quality

Sentec is committed every day to patient care and safety and enhancing customer satisfaction through continual improvement of our products, services, and quality management system.

Committed to Quality

Sentec is committed every day to patient care and safety and enhancing customer satisfaction through continual improvement of our products, services, and quality management system.

We strive to ensure our products and services are of continuous high quality, align with industry standards and are in compliance to laws and regulations world-wide, including but not limited to:

Transcutaneous Monitoring System (SDMS)

  • EU MDR 2017/745

  • MDSAP (download MDSAP Certificate)

    • US FDA 21 CFR Parts 803, 806, 807 and 820
    • Canadian MDR SOR/98-282, Part 1
    • Australian TGR 2002, Schedule 3, Part 1
    • Japanese MHJW Ministerial Ordinance 169, Art. 4 to Art. 68 and PMD Act
    • Brazilian RDC ANVISA n. 16/2013, 23/2012 and 67/2009

  • ISO 13485 (download ISO Certificate)

EIT Monitor (LuMon)

  • ISO 13485

  • EU MDD 93/42/ECC as amended by 2007/47EC

Learn more about Sentec’s products.

Sentec is proud to produce accurate, noninvasive, continuous patient monitoring technologies that help clinicians optimize ventilation for their patients.

Explore Transcutaneous Monitoring
Explore Electrical Impedance Tomography