FDA QMSR Consultant – FDA 21 CFR 820 to ISO 13485 Transition Support

What Is FDA QMSR?

The FDA QMSR final rule modernizes the Quality System Regulation by incorporating ISO 13485 by reference. The objective is to:

• Harmonize U.S. regulatory requirements with international standards

• Reduce duplication between FDA and ISO audits

• Modernize quality system expectations

• Strengthen risk-based controls

This transition requires careful evaluation of existing procedures, documentation, and risk management processes.

Why You May Need an FDA QMSR Consultant

Organizations commonly require support when:

• Transitioning from legacy 21 CFR 820 structure

• Aligning ISO 13485 and FDA expectations

• Preparing for FDA inspections

• Addressing Form 483 observations

• Updating risk management practices

• Revising design control documentation

• Strengthening supplier oversight

The shift requires more than renaming procedures — it requires structural alignment.

Our FDA QMSR Consulting Approach

We provide structured, clause-aligned implementation support.

1. Regulatory Gap Assessment

• Compare current QMS against updated QMSR requirements

• Identify differences between ISO 13485 and existing 820 framework

• Evaluate design controls, CAPA, and risk integration

• Assess supplier and purchasing controls

• Deliver prioritized remediation roadmap

2. System Alignment & Documentation Updates

• Update quality manual and procedures

• Align terminology and structure

• Integrate risk management across processes

• Ensure traceability within design documentation

• Strengthen complaint handling and CAPA workflows

The goal is seamless integration — not parallel systems.

3. Design & Risk Integration

QMSR emphasizes risk-based thinking across:

• Design and development

• Supplier management

• Production controls

• Post-market surveillance

We ensure your risk management framework aligns with ISO 14971 expectations and FDA inspection focus areas.

4. Inspection Readiness Support

• Conduct mock FDA inspection

• Review objective evidence

• Evaluate training records

• Verify complaint handling

• Test traceability and change control

• Prepare leadership for investigator interviews

Inspection readiness reduces regulatory anxiety.

Key Focus Areas Under QMSR

Risk-Based Thinking

Risk must be integrated throughout the QMS — not isolated to a single document.

Design Controls

Bidirectional traceability remains critical.

Supplier Controls

Greater scrutiny on purchasing controls and supplier performance.

Corrective and Preventive Action (CAPA)

Root cause analysis and effectiveness verification must be demonstrable.

Documentation & Record Control

Clear, controlled, and accessible documented information is essential.

Common Gaps We Identify

• Legacy procedures not aligned with ISO 13485 structure

• Inconsistent risk integration

• Weak CAPA documentation

• Incomplete supplier evaluations

• Gaps in complaint trending analysis

• Limited management review outputs

These weaknesses can lead to FDA findings if not addressed proactively.

Benefits of Professional QMSR Transition Support

Working with an experienced FDA QMSR consultant provides:

✔ Reduced inspection risk
✔ Harmonized ISO and FDA compliance
✔ Stronger design control structure
✔ Clear traceability documentation
✔ Improved CAPA effectiveness
✔ Increased regulatory confidence

Transitioning properly avoids costly remediation later.

Who We Support

We work with:

• Medical device manufacturers

• Contract manufacturers

• Software as a Medical Device (SaMD) organizations

• Startup device companies

• Established ISO 13485-certified organizations

• Companies responding to FDA findings

Whether preparing for inspection or proactively transitioning, structured support is critical.

Why Wintersmith Advisory?

We specialize in structured, risk-based quality system implementation for regulated industries.

Our FDA QMSR consulting services are:

• Regulatory-focused

• ISO-aligned

• Risk-driven

• Evidence-based

• Practical and implementable

We build defensible systems that withstand FDA scrutiny.

Preparing for the QMSR Era

The FDA QMSR transition represents a major regulatory shift for U.S. medical device companies.

If you need:

• A QMSR gap assessment

• Full system transition support

• Inspection readiness preparation

• Risk management integration

• CAPA and design control reinforcement

We can structure a clear, defensible path forward.

Regulatory change requires structured action.
Let’s align your QMS correctly.