OPERON ELEVATEPLUS | DRUG-DEVICE COMBINATION PRODUCTS DOCUMENTATION

Drug-Device Combination Products – Regulatory & Development Consulting

Operon Strategist provides specialized consulting for drug-device combination products, helping manufacturers define regulatory pathways, develop compliant design and quality documentation, manage risks, and prepare submission-ready technical files. Our integrated approach reduces regulatory uncertainty and accelerates market entry across global markets.

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Operon ElevatePlus
Drug-Device Combination Products Documentation Service Portfolio

Determine whether the product qualifies as a drug-device combination

Identify applicable regulatory frameworks and approval pathways

Assess primary mode of action and regulatory jurisdiction

Define a clear, market-specific regulatory roadmap

Preparation of design and development documentation aligned with both drug and device requirements

Design inputs, outputs, and technical specifications

Verification and validation documentation

Structured Design History File (DHF) for combination products

Risk analysis and mitigation aligned with ISO 14971

Integration of quality system requirements across device QMS and drug cGMP expectations

Development of compliant procedures for design controls and lifecycle management

Development and implementation of CAPA systems specific to combination products

Root cause analysis and corrective action planning

Change control and documentation traceability for audit readiness

Preparation of documentation for regulatory submissions in major global markets

Support for interactions with regulatory authorities

Response to deficiency letters, queries, and review comments

Harmonized regulatory strategies for multi-country market access

Alignment of development timelines with regulatory expectations

Ongoing compliance support post-approval

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

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

Expert regulatory strategy, design control, and compliance support for drug-device combination products under global regulatory frameworks such as FDA and EU MDR

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

Audit-Ready Documentation & Regulatory Submission Support

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Design History File (DHF)

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US FDA (510(k), QSR & Registration)

SFDA (Saudi Arabia) Registration

CDSCO (India)

Quality Management System (QMS)

Veterinary Medical Devices Registration

BIS Certification

Regulatory Due Diligence for Medical Devices

Planning a Drug-Device Combination Product Approval

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