Hi,
I have more then 7 years of 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,
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