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

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 ISO 14971 risk management processes. CAPA process management: Root Cause investigation and action plans. Change Control: Assessing the impact of changes on registration and quality.

Internal Audit: Conducting an annual certified audit. Supplier Audits: Assessing, approving, and monitoring suppliers. Mock Inspection: Full simulation for an FDA or NB audit. Audit Readiness: Preparing teams, logistics, and "Dos & Don'ts" simulations. Audit Remediation: Writing a response to audit findings.

Lean Quality: Reducing bureaucracy, forms and workloads. Remediation Plans: Recovery plans for existing procedures and systems. eQMS Implementation: Selection, characterization and support for the transition to computerized systems. Production Process Improvement: Reducing work times and lowering scrap rates. Management Review: Preparing and leading periodic management surveys.

External QM: For small/medium sized companies. QA Site Support: Support for day-to-day operations (batch release, document approvals). Temporary Project Management: Support for a specific project (e.g. transition to EU MDR/IVDR).

Filling a position for Quality/QA managers for regulatory continuity.

Onboarding: Initial training for new quality and production employees. Organizational training system: Building and improving the training and testing infrastructure. Annual GMP/GDP training: Mandatory refresher training. Quality manager induction: Personal mentoring for managers at the beginning of their careers.

AI Workshops for Quality Professionals: Using Copilot and Generative Tools in QA. AI Regulation: Advice on the AI Act and New FDA Guidelines.

Automation (No-Code): Building workflows with Make.com to streamline QMS. Implementing eQMS combined with AI: Building workflows according to company procedures. Validation for AI systems: Validating complex algorithms (AI/ML) in medical devices.