Regulatory Gap Analysis & Legacy Device Remediation
Older devices become regulatory liabilities when their documentation isn't maintained. We identify gaps, rebuild traceability, and bring your files up to current standards — before an auditor does it for you.
Don't Wait for a 483 or Audit Deficiency
Many of our clients come to us after receiving FDA Form 483 observations, Notified Body findings, or SFDA registration rejections — often related to legacy devices with unmaintained documentation. Proactive gap analysis is far less costly than reactive remediation.
What Our Gap Analysis Covers
Using FDA- and ISO-based guidelines, including ISO/TR 24971's guidance for retrospective risk assessment, we systematically evaluate your existing documentation and build a prioritized remediation plan.
Multi-Standard Gap Assessment
We map your current practices against ISO 13485:2016, FDA 21 CFR 820 (QMSR), ISO 14971:2019, EU MDR, IEC 62304, and any other applicable standards. The result is a prioritized gap matrix scored by risk and regulatory impact.
- Clause-by-clause ISO 13485 mapping
- Risk-scored gap prioritization
- Phased remediation roadmap with timelines
Traceability Rebuilding
We dive into your existing data and rebuild traceability from customer needs/design inputs to verification/validation results. Every requirement, test, and risk control is linked end-to-end.
- Requirements-to-V&V traceability matrices
- Design history file reconstruction
- Risk-to-controls linkage verification
483 & Audit Response Support
Already received an FDA 483, a Notified Body finding, or SFDA deficiency letter? We help you craft a thorough, evidence-based response and implement corrective actions that prevent recurrence.
- FDA 483 observation response drafting
- CAPA investigation and implementation
- Systemic root cause analysis
Recall Prevention & Proactive Monitoring
We mine years of complaint data and post-market surveillance records to surface previously unrecognized hazards or unacceptable risk trends — catching problems before they become recalls.
- Complaint data trend analysis
- Retrospective risk assessment (ISO/TR 24971)
- Field safety corrective action planning
Is This Service Right for You?
You likely need a gap analysis if:
- → Your device has been on the market for years with minimal DHF updates
- → You're preparing for your first third-party audit or FDA inspection
- → You've received a 483, Warning Letter, or Notified Body finding
- → You're entering a new market (EU MDR, SFDA, Health Canada) with existing products
- → Your risk management file hasn't been updated since ISO 14971:2019
What you'll get:
- ✓ Prioritized gap matrix with risk scores
- ✓ Phased remediation roadmap with timelines
- ✓ Budget estimates for each remediation phase
- ✓ Executive summary for leadership/board presentation
- ✓ Option to proceed directly with remediation
Unsure About Your Compliance Status?
A proactive gap analysis is the most cost-effective way to protect your device, your patients, and your market access. Let's talk about where you stand today.
Request Your Gap Assessment