ISO 13485 + ISO 14971 Integrated Compliance Pack

Separate ISO 13485 and ISO 14971 implementations usually create duplicated records, broken traceability, and slow remediation when issues cross from design into post-market risk control. This integrated pack gives you a connected operating model so quality management and risk management reinforce each other instead of being maintained as parallel systems. That means less time spent rebuilding documents from scratch and a stronger line of evidence when the process is sampled under audit.

What's included

• Integration Roadmap.pdf
• QMS Core Bundle.docx/xlsx
• Design Controls Execution System.docx/xlsx
• Risk Management System.docx/xlsx
• Complaint-CAPA-Risk Update Bridge Pack.pdf
• Role Specific Products > (Complaint
• Management Review KPI Pack.xlsx

Best suited to: Startup manufacturer, Medical device manufacturer, Regulatory consultant, and Quality manager.

Useful in audit situations where you need to:

• Show a structured integrated QMS and risk management process during ISO 13485 certification, surveillance, supplier, or internal audits.
• Support FDA inspections with controlled records, traceability, and process evidence related to integrated QMS and risk management.
• Support EU MDR technical documentation or quality-system reviews where integrated QMS and risk management records need to be complete, controlled, and consistent.

Use this pack to tighten execution, strengthen evidence, and make this part of your ISO 13485 system easier to defend under audit.