Regulatory Services

Led by a certified Lead Auditor (ISO 13485) – Standards Institution of Israel

Whether your organization is aligned with ISO 9001 or operates under the more rigorous ISO 13485, an outstanding audit can make all the difference.
I offer high-caliber internal audits and supplier audits, tailored to your operational complexity and business stage.

Services include:
• Comprehensive internal audits in line with ISO 9001 and ISO 13485 requirements
• Supplier audits for both standards – with detailed documentation and a professional findings report

What sets me apart:
My unique combination of technical expertise, a medical-scientific background, and formal certification as a Lead Auditor for ISO 13485 from the Standards Institution of Israel – ensures each audit is precise, insightful, and genuinely beneficial.

Internal & Supplier Audits
ISO 9001 & ISO 13485