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
