Dear,
I have experience in the following areas:
QMS, MDMS, MDD, TF, CE, RM, PDCA, FMEA, CAPA, Kaizen, Auditing,
Standards: ISO 9001, ISO 13485, FDA 21 CFR 820, ISO 14971, EN 62366, EN 62304, EN 606001,
Planning and implementation processes approach oriented of software, Modeling databases structures and implementation process, Audit of software process,
Developing software - C# .Net and Management of projects, development, expansion and upgrade, Project planning and ensuring project documents.
I am a certified auditor for medical device (ISO 13485) and QMS (ISO 9001).
I am looking forward to hearing your answer.
Best regards,
Aleksandar Siskovic