OPERON ELEVATEPLUS | DRUG-DEVICE COMBINATION PRODUCTS DOCUMENTATION
Drug Device Combination Products Consulting in South Africa
Drug device combination products require specialised regulatory expertise because they combine pharmaceutical and medical device requirements within a single product. Operon Strategist helps South African manufacturers develop compliant documentation, establish quality systems, and navigate global regulatory pathways for successful product commercialisation.
Our multidisciplinary team supports every stage of the product lifecycle—from design and development to technical documentation, risk management, quality management systems, and regulatory submissions. Whether your target market is Europe, the United States, the Middle East, or other international regions, we help simplify complex regulatory requirements and accelerate global market access. Combination products are regulated according to their primary mode of action, and documentation requirements differ between jurisdictions.
Take the next step
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
Regulatory & Documentation Support for Drug Device Combination Products
Developing drug device combination products requires an integrated approach that addresses pharmaceutical, medical device, and quality management requirements. Operon Strategist provides end-to-end consulting services to help manufacturers establish compliant documentation and regulatory strategies for global approvals.
Our services include product classification, regulatory pathway assessment, design and development documentation, Design History Files (DHF), Device Master Records (DMR), risk management, ISO 13485 quality management systems, technical documentation, clinical and performance documentation, manufacturing documentation, and global regulatory submission support. We help manufacturers minimise compliance risks, streamline approvals, and successfully commercialise innovative combination products in international markets. Global regulators such as the FDA and EMA have dedicated frameworks for combination products and associated documentation requirements.
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
frequently asked questions
How are drug device combination products regulated?
They are regulated according to their primary mode of action. Depending on the jurisdiction, the product may be regulated primarily as a medicine or as a medical device, with additional requirements applying to the other component.
How does Operon support combination product development?
We provide regulatory strategy, product classification, technical documentation, design control documentation, ISO 13485 implementation, risk management, and global regulatory submission support throughout the product lifecycle.
Why choose Operon for drug device combination products?
Operon combines expertise in medical devices, pharmaceuticals, quality management systems, and global regulations to deliver practical, end-to-end regulatory and documentation solutions for innovative combination products.
What is CDSCO registration for medical devices in India for South African companies?
CDSCO registration is the regulatory process South African medical device manufacturers may need to follow when seeking to import and market applicable medical devices in India, in accordance with India’s medical device regulatory requirements.