Consulting, strategy and process improvement
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.
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Services for the responsible implementation of artificial intelligence in quality systems
Once you get past the understanding stage, the real question is not whether to use AI but how to do it right, in stages, and without introducing unnecessary risks into the quality system. Our services were built from working with quality, regulatory, and management teams,
And allow the organization to move forward with confidence: from the diagnosis stage to controlled implementation that also withstands scrutiny.
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