OPERON ELEVATEPLUS | REGULATORY DUE DILIGENCE FOR MEDICAL DEVICES
Regulatory Due Diligence for Medical Devices & IVDs
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Operon ElevatePlus
Regulatory Due Diligence for Medical Devices Service Portfolio
Regulatory Pathway & Approval Status Assessment
Validation of device classification and intended use
Review of current and planned regulatory approval routes
Assessment of submission, approval, and commitment status
Identification of approval dependencies impacting deal timelines
Markets covered: US FDA, EU MDR/IVDR, UKCA, CDSCO, SFDA, and other global jurisdictions
Compliance & Documentation Review
Evaluation of technical documentation and dossier completeness
ISO 13485 and Quality Management System compliance assessment
Review of labeling, IFU, claims, and promotional compliance risks
Assessment of Post-Market Surveillance and vigilance obligations
Manufacturing & Quality System Due Diligence
Review of manufacturing licenses and site authorizations
QMS maturity assessment against certification scope
Inspection readiness analysis (FDA, Notified Body, CDSCO)
Review of audit observations, CAPAs, and open nonconformities
Identification of process validation and production control risks
Predicate, Benchmark & Regulatory Precedent Analysis
Identification of comparable approved devices
Review of substantial equivalence and regulatory precedents
Competitive regulatory positioning and approval learnings
Clinical & Evidence Assessment
Review of clinical, performance, usability, and real-world data
Alignment with FDA, EU MDR/IVDR, and global evidence expectations
Identification of evidence gaps and post-market study risks
Regulatory Risk & Liability Assessment
Classification of risks as critical, major, or manageablerformance, usability, and real-world data
Identification of regulatory non-compliance exposure
Approval dependency and enforcement risk evaluation
Estimation of remediation effort, cost, and timeline
What Sets Us Apart
Global Regulatory Expertise Across US, EU, UK, India, GCC & Emerging Markets
Coverage of Medical Devices & IVDs Across All Risk Classes
Experience Supporting Investment, M&A & Strategic Transactions
Proven Insights Aligned with Real-World Approvals & Inspections
Operon Regulatory Due Diligence for Medical Devices Advantage
Independent, Execution-Neutral Regulatory Assessments
Translation of Regulatory Exposure into Business & Valuation Impact
Market-Wise, Approval-Focused Risk Visibility
