Steli Loznen

Steli Loznen, advisor for Implementation of Standards Requirements in Medical Devices.

Expertise:

- International standardization (ISO, IEC, UL, EN, ANSI) for Medical Devices, Laboratory and Information Technology Equipment.
- Product Safety, International Regulatory procedures, Quality Assurance.
- Risk management programs (Hazard identification, Risk Analysis, Risk Evaluation, Risk Control).
- CE Mark (MDD, IVDD, LVD, EMC)
- FDA Procedures and Submission
- ISO 9001 (Quality Systems), ISO 18001 (Environmental), ISO/IEC 17025 (Testing and Calibration), ISO 13485 (Medical Devices manufacturing), ISO 14155-1 (Clinical Trials), ISO/IEC 17065 (Product Certification).