Standards (e.g., IEC 62304), EU Medical Device Regulations, and MDSAP Preferred Qualifications: Direct experience with SDLC...
, CSA, UL, EN, IEC. Experience in standards such as UL1995, UL207, UL984, UL 508, UL508A, UL508C, UL 60335-1, UL 60335-2-34...
of Battery Energy Storage Systems Understanding of using IEC 61131-3 programming standards Experience using high- and low-level...
Manual, SOPs, Local Work Instructions and Methods which in turn ensures compliance with ISO/IEC 17025/AOAC ALACC requirements...
incorporate current global regulatory compliance expectations as required by IEC 62304, ISO 13485, ISO 14971, and other applicable... with In Vitro Diagnostics Extensive knowledge of IEC 62304, ISO 13485, FDA CFR 820, IVDR, ISO 14971 and emerging standards...
, and other international product safety standards, i.e., ANSI, CSA, UL, EN, IEC and CISPR. Ability to apply principles of logic or scientific...
and Regulations (OSHA, IEC): Awareness of safety standards and regulations specific to electrical installations to ensure compliance...
Techniques Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC 62304, FDA’s General Principles...
and IEC applications, including: conduit fittings and cable glands, industrial control and electrical apparatus, enclosures...
), regulatory compliance, and standards such as ISO 9001, ASME, and IEC. Proficiency in quality tools and methodologies (e.g., SPC...