OPERON ELEVATEPLUS
Drug-Device Combination Products – Regulatory & Development Consulting
As a trusted partner for Drug Device Combination Product regulatory consulting, Operon Strategist supports manufacturers in Saudi Arabia with end-to-end documentation and compliance services for combination products. Our expertise covers regulatory strategy, product classification, Primary Mode of Action (PMOA) assessment, design and development documentation, risk management, quality management systems, technical files, and regulatory submissions. We align both drug and medical device regulatory requirements to reduce compliance risks, streamline approvals, and enable successful commercialization across Saudi Arabia and international 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
Global exposure, structured thinking, and execution-ready expertise
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
Drug Device Combination Product Documentation & Regulatory Compliance – We help manufacturers develop compliant documentation and regulatory strategies for Drug Device Combination Products by integrating both pharmaceutical and medical device requirements. Our services include product classification, PMOA assessment, design controls, Design History File (DHF), risk management, technical documentation, Article 117 support, quality management system integration, and regulatory submissions aligned with SFDA, US FDA, EU MDR, ISO 13485, and other international regulations. Our structured approach reduces compliance risks, strengthens audit readiness, and accelerates successful global market approvals.
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
