Build a Strong Compliance Foundation The Design2Comply Compliance Starter Kit is designed for engineering and technical teams who need to quickly establish a structured compliance process. This kit includes the three most essential tools to help you organize, document, and prepare for audits in regulated industries.

• SOP Template – Document procedures consistently with a professional format

• Risk Matrix Template – Identify, assess, and prioritize risks systematically

• Internal Audit Checklist – Track audit findings and maintain audit readiness

• Perfect for teams building a compliance program for ISO 9001, ISO 13485, FDA QSR, or CE requirements

• Saves hours of manual setup with ready-made, professional templates

• Creates a strong foundation for quality and compliance systems

• Ideal for small to mid-sized companies preparing for their first audits

Be Fully Prepared for Internal and External Audits The Design2Comply Audit Readiness Kit gives engineering and compliance teams everything they need to organize, document, and demonstrate compliance during audits. Whether you’re facing ISO, FDA, or CE inspections, this kit ensures that your quality processes and documentation are complete and audit-ready.

• SOP Template – Document procedures consistently

• Risk Matrix Template – Identify, assess, and manage risks

• Internal Audit Checklist – Track findings and maintain readiness

• CAPA Tracker – Document corrective actions and track effectiveness

• ECO Template – Control engineering changes with proper documentation

• Covers documentation, risk management, corrective actions, and change control

• Saves countless hours creating compliance documentation from scratch

• Perfect for small to medium-sized companies preparing for external audits

• Designed for ISO 9001, ISO 13485, FDA QSR, CE, and other regulated environments

All-In-One Compliance Solution for Engineers and Technical Teams The Design2Comply Complete Compliance Toolkit gives you every essential template you need to build, manage, and maintain a compliant quality system. This comprehensive toolkit saves you time, reduces risk, and ensures you are always prepared for internal and external audits.

• SOP Template – Standardize procedures with a professional, compliant format

• Risk Matrix Template – Identify, analyze, and manage risks effectively

• Internal Audit Checklist – Maintain audit readiness year-round

• CAPA Tracker – Log and track corrective actions with root cause analysis

• ECO Template – Control and document design and engineering changes

• Compliance Testing Template – Track testing activities for standards (e.g., IEC, FDA)

• Regulatory Compliance Readiness Checklist – Ensure all areas meet ISO, FDA, and CE requirements

• Bonus tools: Audit log, CAPA root cause worksheet, and more