Armin S

I am a Quality & Regulatory Affairs professional with 10 years of experience in the medical device industry, including 3 years focused on regulatory affairs.

I have hands-on experience working with international standards such as IEC 62304 for medical device software lifecycle processes and IEC 62366 for usability engineering and human factors. My experience includes supporting the development of Software as a Medical Device (SaMD) and ensuring that software development processes align with regulatory expectations.

I am also familiar with software validation for software used in production and quality systems, ensuring that computerized systems comply with regulatory and quality requirements.

In addition, I have extensive experience with risk management and risk assessments, both at the product level and at the business or process level, supporting organizations in identifying and mitigating regulatory and operational risks.

I also have strong general knowledge of ISO 13485 quality management systems, with practical experience in areas such as CAPA management, document control, and quality system processes.