Improver

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.

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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: