مهندس بهار شایان راد

Professional Summary

Experienced Quality Assurance Manager, Management Representative, and PRRC (Person Responsible for Regulatory Compliance) with over 10 years of expertise in the medical device industry. Highly skilled in regulatory compliance, quality management systems, CE certification, clinical evaluation, technical documentation, and MDR 2017/745 implementation. Strong academic foundation in Biomedical Engineering and more than a decade of teaching experience in medical engineering and ISO standards.

Professional Experience

Novatis Teb

Quality Assurance Manager • Management Representative • PRRC
2015 – Present

  • Managing the full Quality Management System (QMS) for devices including hemodialysis chairs, central/portable RO systems, and hemodialysis machines.

  • Preparing, monitoring, and updating technical files for new products and leading the CE certification process.

  • Supervising Post-Market Surveillance (PMS) activities including PSUR and PMCF.

  • Conducting internal audits to evaluate the adequacy and effectiveness of the QMS.

  • Reporting QMS performance directly to company top management.

  • Implementing and teaching MDR 2017/745 requirements within the company.

  • Performing risk assessment, usability engineering, supplier evaluation, and environmental compliance.

  • Leading process validations and establishing quality standards for production lines.

Tosan Company

Production Expert (Neonatal Medical Systems)
2008 – 2012

  • Involved in manufacturing and testing of neonatal systems, including infant incubators, phototherapy equipment, and surgical beds.

  • Performed in-process control, electronic board calibration, and technical testing of devices.

  • Gained foundational experience in production, troubleshooting, and quality control.

NephroCan

CE Consultant
2020 – Present

  • Implemented CE Marking requirements (93/42/EEC).

  • Prepared and audited technical documentation for hemodialysis equipment.

  • Performed compliance analysis and corrective action planning.

TurkaMed

CE Consultant
2022

  • Provided CE compliance consultancy for hemodialysis devices.

  • Ensured alignment with European medical device directives and standards.

University of Applied Sciences / Ebn-e-Sina Center

Lecturer (Part-time)
2014 – Present

  • Teaching medical engineering courses including ISO 13485, QMS structure, and medical equipment fundamentals.

  • Over 10 years of academic lecturing experience.

Association of Manufacturers and Exporters of Medical, Dental, Laboratory & Pharmaceutical Equipment

Instructor (Per-case)
2022 – Present

  • Delivered MDR training programs and usability engineering workshops for medical device manufacturers.

Health Export Development Center

Instructor (Per-case)
2022 – Present

  • Conducted MDR-focused training sessions for regulatory and quality teams in the medical device industry.

Education

Master of Science — Biomedical Engineering (Bioelectric)

  • Thesis: Simulation of human cerebellum and motor dynamics.

Bachelor of Science — Biomedical / Engineering Background

  • Training and academic focus in technical and engineering foundation essential for medical device development.

Certifications & Technical Competencies

  • MDR 2017/745 (PSUR, PMCF, Vigilance, Trend Reporting)

  • ISO 13485, ISO 9001, ISO 14971

  • EN 60601-1, EN 60601-1-8, EN 60601-1-11

  • EN 60601-2-16, EN 62304 (Software Lifecycle)

  • ISO 62366-1 (Usability Engineering)

  • EN 23500 (Hemodialysis Water Treatment)

  • Medical Device Cybersecurity Requirements

  • MDCG Guidance for Active Medical Devices

Key Responsibilities & Expertise

  • Quality Management: QMS planning, implementation, monitoring, effectiveness review.

  • Regulatory Compliance: Technical file preparation, licensing, CE Marking.

  • Post-Market Surveillance: PMCF/PSUR planning and execution.

  • Internal Audits: Full-cycle audit execution and reporting.

  • Risk Management: ISO 14971–based risk assessment and documentation.

  • Supplier Evaluation: Qualification and periodic assessment of critical suppliers.

  • Usability Engineering: Formative and summative usability assessments.

  • Process Validation: Validation planning, execution, and reporting.

  • Training: MDR, ISO standards, and medical device regulatory education.

Publications

  • Learning and control model of cerebellum during reaching movements: a simulation study (M.Sc. Thesis)

  • Research papers presented at:

    • 2nd International Congress of Electrical Engineering (2015)

    • 1st International Soft Computing in Engineering (2015)

    • 3rd RSI International Conference on Robotics & Mechatronics — IEEE Indexed (2016)

    • 4th World Kidney Congress (2019) — Hemodialysis water quality & clinical evaluation

Lectures & Training Delivered

  • ISO 62366-1 — Usability Engineering (8 hours)

  • Differences between MDD & MDR (8 hours)

  • Clinical Evaluation under MDR (8 hours)

  • Change Assessment — MDCG 2020-3 (8 hours)

  • IEC 62304 — Software Lifecycle (multiple sessions, 2024)

  • Medical Device Cybersecurity (8 hours)

  • MDCG Guidance for Active Devices (4 hours)

Professional Interests

  • Medical device research and innovation

  • Academic teaching and scientific writing

  • Participation in medical engineering conferences

  • Continuous study of regulatory and engineering standards

تخصص: edical Device Quality Systems, Compliance & Training Expert

!

هیچ مطلبی یافت نشد

متاسفیم، مطلبی مرتبط با جستجوی شما پیدا نشد.