Expertise & Discovery-Led Quality Engineering

ENQUAL’s expertise is grounded in structured discovery, technical depth, and disciplined execution within regulated environments. Rather than starting with predefined solutions, ENQUAL focuses on understanding regulatory context, inspection exposure, and decision logic before recommendations are made.

This approach reflects how regulatory outcomes are achieved in practice:
through clear decisions, defensible rationale, and traceable documentation, not document volume.

Structured discovery establishes regulatory context, inspection exposure, and decision gaps before execution begins—ensuring remediation efforts are targeted, defensible, and sustainable. 

Every engagement begins with structured discovery to establish:

• Regulatory context (FDA, EU MDR, combination product considerations)
   
• Inspection exposure and risk posture
   
• Design control and risk management maturity
   
• Where decisions are unclear, unsupported, or misaligned
   

Discovery is intentionally separated from execution so that:

• Risk is understood before scope is defined
   
• Recommendations are targeted, not generic
   
• Leadership can see where control truly sits
   

This discovery-driven model supports credible prioritization and avoids unnecessary remediation.

ENQUAL supports organizations where design, risk, and regulatory expectations intersect, particularly in complex or evolving product environments.

• Design verification strategy and execution support
   
• Statistical rationale development and data interpretation
   
• Traceability between design inputs, verification evidence, and risk controls
   
• DHF development, remediation, and sustainment

•  Lifecycle risk management file development and remediation
   
• Hazard analysis and integrated FMEA (dFMEA, uFMEA, pFMEA)
   
• User task analysis and usability-related risk considerations
   
• Alignment of risk controls to verification evidence and design controls

• Design change impact assessment and documentation
   
• DHF and RMF continuity during design, process, and supplier changes
   
• Evaluation of downstream effects to verification and risk assumptions
   
• Support for cross-functional change decision-making

• Inspection readiness assessments and gap identification
   
• CAPA and remediation support
   
• Regulator-defensible documentation practices
   
• Support during periods of heightened regulatory scrutiny

ENQUAL’s work is grounded in current regulatory and consensus standards, including:

• FDA 21 CFR 820 / QSR
   
• ISO 13485
   
• ISO 14971
   
• EU MDR (2017/745)
   
• IEC 62304 (software lifecycle – supporting scope)
   
• IEC 60601 / IEC 62366 (as applicable to product context)
   
• ICH Q8, Q9, Q10 (for combination product environments)
   

Statistical analysis is performed using tools appropriate to the context, including Minitab and JMP, with emphasis on assumption transparency and decision logic.

ENQUAL has supported quality and regulatory activities across a range of regulated products, including:

• Combination products (drug–device)
   
• Parenteral drug delivery systems
   
• Electromechanical medical devices
   
• In vitro diagnostics (IVD)
   
• Biopharmaceutical manufacturing systems
   
• Purified water and utility systems
   

Experience spans both legacy product remediation and active product lifecycle support.

The Expertise described above informs how ENQUAL delivers services, but does not replace structured discovery or predefined engagement models.

Representative examples of this work are available in the Evidence Hub, which presents anonymized case studies illustrating:

• Design verification statistical rationale
   
• Lifecycle risk management system development
   
• Design change and sterilization impact control
   

These examples reflect the application of ENQUAL’s expertise in real-world quality and regulatory environments.