: Previous experience with health authority meetings/interactions Experience with medical device software guidance, IEC 60601...
/IEC, and local regulatory authority for diagnostic & assay development regulations. PREFERRED QUALIFICATIONS | EDUCATION...
/IEC, and local regulatory authority for diagnostic & assay development regulations. PREFERRED QUALIFICATIONS | EDUCATION...
, Statistica), Familiar with IEC 60601 and product specific industry standards. Excellent interpersonal and influence skills...
and other related codes and standards of ANSI, ASME, ASTM, CGA, ALPEMA, API, IEC, NACE, NEC and NFPA. Willingness to spend extended...
Start up experience Knowledge of 21 CFR 820, ISO 13485:2016, and IEC 62304:2006 Experience with C++ & Python My client...
-26262 or IEC 61508 or DO178 or similar standards Collaborate with vendors and cross-functional team to perform feasibility...
. Demonstrate understanding of and alignment to FDA, ISO, and IEC design control procedures, regulations, and standards within the...
, and external spend. Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations...
of US and international medical device regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, IEC 82304, AAMI TIR45, ISO 14971..., AAMI TIR57, IEC 60601 series, IEC 62366. Solid understanding of developmental best practices for medical device software...