OPERON ELEVATEPLUS | DRUG-DEVICE COMBINATION PRODUCTS DOCUMENTATION
Drug-Device Combination Products – Regulatory & Development Consulting
Operon Strategist provides specialized consulting for drug-device combination products, supporting manufacturers in defining regulatory pathways, preparing compliant design and development documentation, managing product risks, and compiling submission-ready technical files.
Our integrated approach aligns both drug and medical device regulatory requirements, reducing uncertainty and accelerating market access across global markets.
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Operon ElevatePlus
Drug-Device Combination Products Documentation Service Portfolio
Regulatory Strategy & Product Classification
Determine drug-device combination product classification and regulatory applicability
Identify applicable regulatory pathways under FDA 21 CFR Part 4, 21 CFR Part 820/QMSR, EU MDR 2017/745, ISO 13485, ISO 14971 & ICH guidelines
Assess Primary Mode of Action (PMOA) and lead regulatory authority
Develop market-specific regulatory and approval strategy roadmap
Design & Development Documentation
Design planning, user needs, design inputs & outputs documentation
Design transfer, change control, Structured Design History File (DHF) & Device Master Record (DMR) documentation
Design verification, validation & design review documentation support
Technical File, Design Dossier & Product Specifications File preparation for global compliance
Risk Management & Quality Systems
ISO 14971-compliant Risk Management File, hazard identification & risk analysis
Use-related risk analysis, FMEA/dFMEA/pFMEA & Fault Tree Analysis (FTA)
Benefit-risk evaluation, risk control, residual risk & post-production risk review
IEC 62366-1 usability engineering, human factors & formative/summative studies
GSPR & Essential Requirements Compliance
EU MDR Annex I General Safety & Performance Requirements (GSPR) checklist preparation
Mapping of applicable standards, testing evidence & compliance documentation
Essential Requirements Checklist support for legacy MDD products
GSPR compliance review aligned with EU MDR technical documentation requirements
Technical Documentation & Validation Support
Product description, intended use, formulation & device specification documentation
Clinical evaluation, clinical evidence, performance testing & software documentation
Biocompatibility, sterilization, packaging & shelf-life validation documentation
Labeling, IFU, CAPA, complaint handling, PMS & PMCF documentation support
Article 117 of EU MDR 2017/745 amends Directive 2001/83/EC & Notified Body Opinion (NBOp) Support
Article 117 of EU MDR 2017/745 amends Directive 2001/83/EC applicability assessment for medicinal products with device components
Technical documentation, GSPR, risk management & usability evidence compilation
Coordination with Notified Bodies (NB) and deficiency response support
Support for NB review of design, clinical, IFU, sterility & packaging validation documentation
What Sets Us Apart
Extensive Experience Across Drug, Device & Combination Product Regulations
Expertise in FDA 21 CFR Part 4, 21 CFR Part 820, ISO 13485, & EU MDR Requirements
Global Consulting Support from Concept Development to Regulatory Submission
Proven Capability in Risk Management, CAPA, DHF & Audit Readiness
Regulatory and documentation support for drug–device combination products – we support manufacturers in navigating complex regulatory pathways through integrated strategy and documentation development. Our services include product classification, regulatory pathway assessment, design and risk documentation, and implementation of CAPA and quality systems. This structured approach reduces regulatory risk, strengthens audit readiness, and enables timely progression toward market approval.
Operon Drug-Device Combination Products Documentation Advantage
End-to-End Regulatory Consulting for Drug-Device Combination Products
Integrated Approach Covering Both Drug & Device Compliance Requirements
Strong Alignment with Quality Management & Design Control Systems
