Structuring Vigilance: A Visual Guide to MDSAP Ready Documentation in Medical Devices

By Vesna Drazenovic September 19, 2025 | Sydney, Australia

If you have ever lost time hunting for the latest vigilance report or worse, had an auditor point out a missing document?  You know that folder chaos is more than an inconvenience.  It is a compliance risk.  That is where structured, MDSAP ready documentation makes all the difference.

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo one audit that satisfies multiple regulatory authorities, including:

• U.S. FDA
• Health Canada
• Japan’s MHLW, PMDA
• Brazil’s ANVISA
• Australia’s TGA

Instead of managing separate audits for each market, MDSAP enables companies to demonstrate compliance through a single, harmonized audit framework. For growing medical device companies, this reduces duplication, lowers costs, and speeds up global market access.

Why MDSAP Ready documentation matters?

In the world of medical devices, vigilance isn’t just a regulatory requirement it’s a reflection of ethical governance and operational maturity. Whether you're preparing for an MDSAP audit or building scalable systems for global compliance, your folder structure matters.

Today, I’m sharing a folder framework designed for clarity, traceability, and audit readiness especially for SharePoint environments.

Why Folder Structure Matters?

A well-structured vigilance repository:

• Ensures rapid retrieval during audits
• Links complaints, CAPAs, and regulatory submissions
• Supports ISO 13485, EU MDR, and TGA alignment
• Reduces risk of non-compliance due to missing or misfiled documentation

The MDSAP-Aligned Vigilance Folder Map

Vigilance Documentation folder naming reference:

01 Procedures_and_Policies
02 Incident_Reports
03 Regulatory_Submissions
04 Customer_Complaints
05 CAPA_and_Risk_Assessment
06 Communication_and_Change_Notifications
07 Training_and_Awareness
08 Audit_and_Review

Each folder is prefixed numerically for logical flow and audit efficiency. Content herewith:

01_Procedures_and_Policies

•  SOPs for vigilance, complaints, and adverse events
• Regional reporting requirements (FDA, TGA, Health Canada)

02_Incident_Reports

• Initial, follow-up, and final reports
• Event classification logs

03_Regulatory_Submissions

• Country specific reports (FDA MDR, TGA, ANVISA, PMDA)
• Submission timelines and correspondence

04_Customer_Complaints

• Complaint logs and investigations
• CAPA linked cases and closure reports

05_CAPA_and_Risk_Assessment

• CAPA records tied to incidents
• Risk assessments, FMEA, and effectiveness checks

06_Communication_and_Notifications

• Internal alerts and stakeholder updates
• Field safety notices and recall communications

07_Training_and_Awareness

• Vigilance training records and competency logs
• Refresher materials and sign-offs

08_Audit_and_Review

• Internal audit reports and MDSAP responses
• Management reviews and continuous improvement logs