TETRATRONICS Sdn BHd
Medical Device Consultancy
We provide consultancy professional service to the medical device industry to consistently meet all relevant requirements related to Quality Management System (QMS) ISO 1348:2016, Quality System (QS) FDA 21 CFR 820, Medical Device Regulation EU MDR 2017/745, and other country regulations such as MDA, CFDA, MHRA and UKCA.
Email us at admin@tetratronics.com for more information
Support & Documentation
Mainly focusing on EU MDR 2017/745 regulation technical documentation requirements, Declaration of Conformity, EUDAMED, UDI, Mandate of EU REP, Risk Management, GSPR, PMS, Design and Development, External Laboratories testing to meet general safety performance clauses and relevant documentations.
(1352399V)