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Hadar Friedman

Hadar Friedman

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The strategic guide to implementing quality AI according to ISO 13485 and QMSR standards

The Quality Manager of 2026: Why AI Certification is the New Standard

Strategy and Quality: How to Convince the CEO to Implement Artificial Intelligence

FDA audit coach simulation- Live

How to Implement AI in MedTech Quality System

Validation & Engineering

TMV (Test Method Validation): Validation of test methods.
Process Validation: Validation of production processes (IQ, OQ, PQ).
Equipment Qualification: Infrastructure and equipment qualification.
Cleaning Validation: Validation of cleaning and disinfection processes.
CSV/SWV: Validation of computer systems and software.

Establishing and managing quality systems (QMS & Compliance)

Establishing a QMS from scratch: Building a quality system for startup companies.
Compliance with international standards: ISO 13485, ISO 9001, MDSAP.
Preparation for FDA submissions: Building the Quality section in the technical file (510k, PMA).
Risk Management: Improving risk management processes ISO 14971.
CAPA process management: root cause investigation and action plans.
Change Control: Evaluating the impact of changes on registration and quality.

Audits & Inspection

Internal Audit: Conducting a certified annual audit.
Supplier Audits: Evaluation, approval and control of suppliers.
Mock Inspection: Complete simulation for an FDA or Notified Body (NB) audit.
Audit Readiness: Team preparation, logistics and "Dos & Don'ts" simulations.
Audit Remediation: Writing a response to audit findings.

Process improvement and organizational efficiency (Operational Excellence)

Lean Quality: Reducing bureaucracy, forms, and workloads.
Remediation Plans: Remediation plans for existing procedures and systems.
Implementing eQMS: selection, characterization and support for transitioning to computerized systems.
Improving production processes: reducing working times and lowering scrap rates.
Management Review: Preparation and leadership of periodic management surveys.

Knowledge & Training

Outsourcing & Staffing

Maternity leave replacement: filling in for quality managers/QA for regulatory continuity.
External QM: for small/medium-sized companies.
QA Site Support: supporting the day-to-day operations of the organization (batch release, document approvals).
Temporary project management: supporting a specific project (e.g. transition to EU MDR/IVDR).

Training & Mentoring

Onboarding: Initial training for new quality and production employees.
Organizational training system: Building and improving the training and testing infrastructure.
Annual GMP/GDP training: Refresher training is mandatory.
Initiation of quality managers: Personal mentoring for managers in their early stages.

Technology and Artificial Intelligence (AI & Quality)

AI workshops for quality professionals: Using Copilot and generative tools in QA.
Automations (No-Code): Building workflows with Make.com to streamline the QMS.
Implementing eQMS combined with AI: Building workflows in accordance with company procedures.
Validation for AI systems: Validation of complex algorithms (AI/ML) in medical devices.
AI Regulation: Advice on the AI Act and new FDA guidelines.
Prompt Engineering for regulation: Writing work instructions for using AI in an organization.

+972 524411484

hadarl1307@gmail.com

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