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Nimrod Epstein, PhD. (Biology)

Nimrod Epstein, PhD. (Biology)

Head of Regulatory Affairs and Quality, Aidoc Medical

Israel

PhD in Biology from the Univ. of Amsterdam (Physiology and ecology of reefs).

Since 2018 I had the unique privilege of being in charge - hands-on - of AIDOC's FDA PMN submissions of 7 Artificial Intelligence, Deep Learning Algorithms for Analysis of Radiological Images. Within just 2 Y time, we obtained clearances for ICH, LVO, CSF, PE/iPE, IFG (intra-abdominal free gas), and Rib Fractures for our BriefCase Computer-Assisted Triage Software.

Aidoc is a blessed rising star in the digital healthcare world.

Before Aidoc, from 2006 I held positions as a medical device Regulatory and Quality (RA/QA) manager in various medical companies (sleep Apnea assessment, SW integrated sensors on a mobile platform for ECG and SpO2 monitoring, radiotherapy, medical flow meters, an invasive surgical device for laparoscopic procedures, wearable RF device for pulmonary fluid measurement).

I bring with me experience and deep understanding in:
1) Medical innovations;
2) The special needs of medical innovation for reaching the market;
3) Regulatory Strategy and compiling PMN 510(k) submissions, pre-submissions, 513g (RFI), Technical Files, Helsinki submissions, support to clinical studies, Israeli AMAR, Health Canada applications.
4) Establishment of QMS from scratch in compliance with Regulation 2017/745 and ISO 13485, QSR and HC MDR.
5) Inter-relationships between processes, tailoring of both quality processes and regulatory strategy to the organization's specific needs.

• Certified Lead Auditor: ISO 13485/9001 (SII)
• Quality Control (SII)

More:
- Annual Certification
- Quality Management in design, V&V Verification & Validation, in-house manufacture control, supplier certification and control, labeling, distribution of Class IIb medical devices.
- Clinical Evaluation and Risk Management Life Cycle.
- PMS (Post Market Surveillance), Complaint Management.


Experience:

  • Head of Regulatory and Quality (Aidoc Medical)
  • QA/RA Manager (Azimuth Therapy Ltd.)
  • RA/QA Manager (VASA Applied Technologies)
  • Regulatory & Quality Manager (G Medical Innovations)
  • Medical Device Quality and Regulatory Consultant (Gold Ventures Incubator)
  • GVI, Medical Device Regulatory/Quality Expert (RA/QA) (Gold Ventures Incubator)

Skills:

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