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Questionnaire for course participants to tailor the content to your needs

The course was built for you. Fill out the short questionnaire (2 minutes) so I can adapt the content, examples, and exercises to your daily work. You can fill it out in Hebrew/English for your convenience.

Registration for "Artificial Intelligence in Medical Device Quality Systems"

QABOOST

Full name*

Job Title*

Company name*

How would you rate your current experience with GPT?*

None

Basic (free plan)

Intermidiate (Plus plan, only chat)

Advanced (Plus plan, Agentic AI)

Other

Have you used GPT or other AI tools in your daily work?*

Yes

No

Have you ever built a GPT agent or automation?*

Yes

No

What topics would you most like to learn in this course?*

Do you know what a "prompt" is and how to write one?*

Yes

Somewhat

No

Blog Posts

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Services

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.

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