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.
Invite me to your organization for personalized training
Quality System Enhancements
QMS Optimization, Design Transfer & TMV Support, Supplier Management, Change Control & CAPA Systems, etc..
Boutique sessions (3–5 participants) focused on AI adoption, risk management, and compliance.
Custom training programs for QA, RA, R&D, and Operations teams.
AI in MedTech COPILOT microsoft 365 workshops
Full-day in-person/remote building Copilot Agents using QABOOST Methodology.
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.
AI Quality Assessment
Controlled implementation support until audit readiness, hands-on support for teams moving from the planning phase to actual use.
What the service includes:
Supporting QA and Process Owners, defining Human-in-the-Loop points, training users on correct and defined usage, preparing for expected audit questions
What you will get in the end:
Controlled, not “improvised” use, a team that knows how to explain what they are doing and why, and an implementation that does not fall apart under the pressure of criticism.
AI Governance & Control Framework
A practical approach to validation that doesn't try to prove impossible things.
What the service includes:
Defining a risk-based validation strategy, determining behavioral Acceptance Criteria, building test scenarios (including edge cases), connecting to IQ/OQ/PQ where relevant – without overloading
​
What you will get in the end:
An explainable validation framework, documentation that speaks the language of an auditor, confidence that the AI is controlled, even if it is not deterministic, is suitable for organizations that introduce AI into significant quality processes.
Validation Strategy for AI Tools
Building a control framework for AI within the QMS is not a theoretical policy but a framework that works on a daily basis.
What the service includes:
Defining Intended Use and Out of Scope for each use, clear division of responsibility: QA, IT, management and users, defining operational controls, monitoring usage and triggers for revalidation, connection to existing QMS documents (procedures, change control, training)
What you will get in the end:
A clear framework that allows the use of AI without a "gray area" A uniform language between quality, IT, and management A strong foundation that also holds up to scrutiny Suitable for organizations that already use AI and want control, not firefighting.
Audit Ready AI Implementation
AI utility mapping and regulatory risk assessment
A focused and brief examination that aims to understand where the organization really stands today.
What the service includes:
Mapping existing AI uses (including “unofficial” ones), classifying Use Cases by risk level and impact on quality decisions
Identifying gaps against regulatory requirements and audit expectations, distinguishing between permitted, borderline, and problematic uses
What you will get in the end:
A clear picture of the situation, a focused list of risks, a practical recommendation: what to stop, what to regulate, and what can be expanded.
Suitable for organizations that want to understand the situation before deciding on implementation or investment.
Let’s Work Together
Get in touch so we can start working together.
