Your path to certification, cleared.
I guide companies through the full compliance journey — from gap analysis to successful audit. Deep regulatory expertise, structured methodology, proven results.
Compliance for Your Standard
Specialized consulting for regulated industries — quality, medical devices, and cybersecurity.
ISO 9001
End of bureaucracy — structured gap analysis and implementation that gets your QMS audit-ready.
Automate your QMS nowISO 13485
Medical device compliance without the headache — from QMS design to successful certification audit.
Get audit securityMDR / IVDR
Navigate the regulatory complexity — technical documentation, clinical evaluation, and CE marking.
Book strategy sessionEU 2024/2478
Be ready before everyone else — Cyber Resilience Act gap analysis and compliance roadmap.
Start CRA gap analysisISO/SAE 21434
No TARA, no contract — automotive cybersecurity engineering from concept to decommission.
Check automotive securityIEC 62443
The firewall for your production — industrial cybersecurity from risk assessment to zone architecture.
OT security consultationISO 14001
Environmental Management System — coming soon.
ISO 45001
Occupational Health & Safety Management — coming soon.
ISO 27001
Information security as a competitive advantage — ISMS implementation and certification support.
Accelerate certificationFrom Gap Analysis to Successful Audit
A proven five-step methodology that takes you from initial assessment to certification — and beyond.
Gap Analysis
Comprehensive assessment of your current state against the target standard. I identify gaps, risks, and quick wins to build a clear roadmap.
Implementation
Systematic build-out of your management system — processes, policies, and controls tailored to your organization, not generic templates.
Evidence Collection
Structured gathering and organization of audit evidence. Central documentation that proves conformity and makes audit day straightforward.
Audit Preparation
Mock audits, team coaching, and final review. I ensure your team is confident and your documentation is audit-ready.
Continuous Improvement
Post-certification support to maintain and improve your management system. Surveillance audit prep and ongoing optimization.
Tools & Approach for Continuous Compliance
Structured systems and proven tools that make compliance manageable, measurable, and maintainable.
Central Evidence Collection
One source of truth for all compliance evidence. No more scattered files, lost emails, or duplicated effort across teams.
Systematic Gap Analysis
Clause-by-clause assessment against the standard requirements. Clear status tracking, priority scoring, and actionable remediation plans.
Audit-Ready Documentation
Documentation that auditors love — clear, complete, and well-structured. Every policy, procedure, and record exactly where it should be.
Multi-Standard Management
Integrated management systems that cover multiple standards efficiently. Shared controls, unified processes, one audit — multiple certifications.
How My Clients Achieved Compliance
ISO 13485 & MDR in 6 Months
A medical device startup needed both ISO 13485 certification and MDR compliance before their product launch. I built an integrated QMS from scratch and guided them through a successful first-time audit.
Read case study
ISO/SAE 21434 Implementation
A tier-2 automotive supplier required cybersecurity engineering compliance. I implemented the full ISO/SAE 21434 framework, including threat analysis, risk assessment, and cybersecurity management system.
Read case study
EU 2024/2478 Ready
An IoT platform provider needed to meet the new EU Cyber Resilience Act requirements. I conducted a comprehensive gap analysis and implemented all necessary security controls ahead of the compliance deadline.
Read case study
Your Compliance Architect
I combine deep regulatory expertise with structured, pragmatic methodology. No templates, no guesswork — just clear paths to audit success, tailored to your specific situation.
Ready to tackle your compliance challenge?
Let's talk. Concrete, no-obligation, tailored to your situation. I'll give you an honest assessment and a clear path forward.