in compliance with FDA's Quality System Regulation, Medical Device Directive (MDD), ISO 13485, Canadian CMDR, and other quality...
. 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/ Medical Device Regulation (MDR... Techniques Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC 62304, FDA’s General Principles...
: Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD...
: Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD...
of calcified plaque. Position Overview In compliance with FDA, European MDD/MDR & ISO regulations, the Senior Quality...
Quality System Regulations (QSR), Medical Device Directive (MDD), and applicable ISO requirements for medical device..., or equivalent preferred Thorough knowledge and understanding of FDA QSRs, ISO standards, and the MDD Knowledge...
risk management file updates. Assure products meet regulatory requirements for risk management, including FDA QSR, MDD, EU...
Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements), including providing support...
-on experience with FDA, QSR, ISO, MDD, GDP, GLP, GMP and/or other local or international quality systems requirements. Utilize...
Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements), including providing support...