Core Service Architecture

1. The 2026 QMSR Transition Audit

Scope of Assessment: A comprehensive evaluation comparing your legacy FDA 21 CFR Part 820 Quality System against the newly enacted ISO 13485:2016 alignment under the Quality Management System Regulation (QMSR).

Strategic Additions:
• Comprehensive Regulatory Requirement Mapping: Line-by-line cross-referencing of your existing procedures against QMSR mandates.
• Risk Assessment & Priority Scoring: High-risk systemic vulnerabilities are scored to ensure immediate triage of critical compliance blind spots.
• Root Cause Analysis for Systemic Issues: Identifying why legacy procedures diverged to prevent recurring non-compliance.

The Deliverable: A high-utility, interactive Compliance Scorecard mapping out exactly which SOPs require updating and which forms are missing, paired with a step-by-step productization roadmap to smoothly transition your operational culture without disrupting active manufacturing cycles.

2. Pre-Submission / Submission Readiness Audit

Scope of Assessment: A thorough pre-market gate review of a startup or emerging firm’s existing bench testing data, software documentation (including CSA/CSV frameworks), and risk files before investing critical capital into writing a formal FDA submission or Pre-Submission.

Strategic Additions:
• Comprehensive Regulatory Requirement Mapping: Verifying technical files against specific submission guidance endpoints.
• Risk Assessment & Priority Scoring: Evaluation of data anomalies or documentation gaps that trigger regulatory rejection or immediate holds.
• Root Cause Analysis for Systemic Issues: Investigating design history discrepancies to reinforce data integrity protocols.

The Deliverable: A clear, high-visibility Traffic-Light Report (Red/Yellow/Green) detailing specific vulnerabilities in predicate device arguments, software lifecycle documentation, or risk mitigations, establishing a clear line of sight to a defensible submission package.

Unbundled Standalone Offerings

1. Isolated Regulatory Requirement Mapping (The “Traceability Blueprint”) – $3,000

• The Problem It Solves: Companies often have strong engineering or scientific documentation but lack the precise “regulatory language” or cross-referencing required to pass a logic audit by an FDA or EU reviewer.
• What It Is: A standalone mapping sprint that acts as a translator between raw technical files and strict regulatory expectations.
• How We Apply Regulatory Logic: We map your specific product features, manufacturing lines, or clinical data against 21 CFR Part 11, Part 820/QMSR, or EU MDR Annex I (GSPRs).
• The Deliverable: A comprehensive Compliance Matrix that links every engineering requirement or process step directly to an explicit regulatory statute, ensuring zero unmapped parameters before an official review.

2. Risk Assessment & Priority Scoring Sprint – $3,500

• The Problem It Solves: Startups frequently mistake basic engineering hazard lists for a compliant, audited risk portfolio. They fail to prioritize which vulnerabilities will actually cause a clinical hold or a devastating regulatory finding.
• What It Is: A deep-dive audit focused exclusively on your risk management architecture (ISO 14971 or ICH Q9).
• How We Apply Regulatory Logic: We evaluate how your system scoring correlates with data reality. We audit your FMEAs or software safety assessments to see if your mitigations are verifiable or if they are simply a “mirage.”
• The Deliverable: A Risk Prioritization Scorecard featuring an interactive risk matrix that ranks vulnerabilities by clinical and regulatory severity, giving your team an immediate, objective execution roadmap for engineering remediation.

3. Systemic Root Cause Analysis (RCA) Diagnostics – $3,500

• The Problem It Solves: When a firm experiences a recurring technical failure, an unexpected lab result, or a system breakdown, they often patch the symptom instead of fixing the root cause, leading straight to a systemic FDA Form 483 or warning letter.
• What It Is: A rapid-response, forensic investigation into a specific operational or technical failure.
• How We Apply Regulatory Logic: Utilizing structured methodologies (such as 5 Whys, Fishbone, or Fault Tree Analysis) bounded by 21 CFR 820.100 (CAPA) and ICH Q10, we audit the history of the failure to find the breakdown in documentation or process logic.
• The Deliverable: A formal, audit-defensible Root Cause Analysis & Logic Audit Report that can be inserted directly into a CAPA file, proving to regulatory investigators that you possess a rigorous, self-correcting quality culture.

The Foundations of Our Diagnostic Rigor

Every audit and evaluation we execute is bound to the exact technical and regulatory frameworks used by global field investigators and reviewers. Our analysis spans across:

 

• U.S. FDA Regulations: 21 CFR Parts 210, 211 (Pharma GMP), 600–680 (Biologics), 807 (510k), 812 (IDE), 814 (PMA), 820 (QMSR), Part 11 (Electronic Records/Signatures), and all active, applicable guidance documents.
• EU and International Regulations: EU MDR (Medical Devices), IVDR (In Vitro Diagnostics), ISO 13485:2016 (Quality Systems), ISO 14971:2019 (Risk Management), MDSAP (Medical Device Single Audit Program), PIC/S GMP, and WHO standards.
• ICH Guidelines: Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), Q10 (Pharmaceutical Quality System), Q11 (Development and Manufacture of Drug Substances), E6 (GCP), and M4 (Common Technical Document).

• Universal GxP Standards: Applied systematically across all R&D, commercial manufacturing, and clinical operations.

How We Apply Regulatory Logic to This Model
True regulatory logic requires treating a quality management system or submission dossier not as a collection of isolated files, but as a deeply interconnected, pressure-tested ecosystem. When an auditor or reviewer evaluates your documentation, they look for harmony between what was intended, what was executed, and what was recorded.

 

Our diagnostic methodology applies this logic by moving past superficial checklist validation. We trace the lineage of your data and procedures. For instance, if an engineering change is made, our regulatory logic interrogates how that change ripples through your ISO 14971 risk analysis, updates your software assurance logs (CSA), alters manufacturing SOPs, and affects your training matrices. If a system gap is identified, we don’t just note the symptom; we use rapid root cause analysis to discover why the documentation system allowed the gap to form. This ensures your final remediation is robust enough to easily withstand subsequent regulatory cross-examination.

 

The Execution Roadmap Deliverable
A gap analysis is only as valuable as the execution it inspires. Every deficiency uncovered during our audit is funneled directly into a structured, audit-ready Execution Roadmap formatted for seamless integration into your internal quality or engineering systems:

 

Element Operational Definition & Content
1. Deficiency Description A plain-language, low-ambiguity statement describing the exact process, record, or technical element that is missing or non-compliant.
2. Regulatory Reference The exact CFR section, ICH guideline clause, or ISO standard paragraph violated or left unaddressed.
3. Corrective Action Required (CAPA) Specific, highly technical, or procedural remediation steps required by your QA/RA and engineering teams to completely close the gap.
4. Ownership & Timelines Assigned cross-functional leads and hard, defensible calendar target dates for execution and closure.

 

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