Drug-Device Combination Product Consultant in Algeria
Expert Consultation for Drug-Device Combination Products
At Operon Strategist, we provide specialized consultancy services for drug-device combination products in Algeria, supporting manufacturers with seamless regulatory compliance, project execution, and global approvals.
Our end-to-end support covers:
- Risk Management
- EU MDR 2017/745 alignment
- Design Control under 21 CFR Part 820
- CAPA (Corrective & Preventive Action) Management
- ISO 13485:2016 QMS Implementation
With our expertise, Algerian manufacturers can confidently navigate complex regulations and achieve successful entry into local and global markets.
What Are Drug-Device Combination Products?
Drug-device combination products are innovative solutions that integrate a drug, device, biologic, or a mix of these into a single product or system.
Defined under 21 CFR 3.2(e), these products offer combined therapeutic or diagnostic functions, improving patient outcomes and treatment efficiency.
Examples include:
Drug-eluting stents – supporting blood vessels while releasing medication
Pre-filled syringes & injectors – improving dosing accuracy
Inhalers & infusion pumps – delivering medicines effectively
These innovations are shaping the future of healthcare, extending even into nutraceuticals and cosmeceuticals.
Types of Drug-Device Combination Products
The FDA classifies combination products under 21 CFR 3.2(e) into:
- Single-Entity Products – integrated drug + device (e.g., drug-eluting stents, prefilled syringes).
- Co-Packaged Products – packaged together (e.g., vaccine vial with syringe).
- Cross-Labeled Products – separately packaged but intended for joint use (e.g., drug with infusion pump).
Combination Products Project Development & Design Control
Pharmaceutical and medical device organizations manufacturing combination products must comply with dual regulatory requirements:
- 21 CFR Part 210 & 211 – Drug GMP regulations
- 21 CFR Part 820 – Device Quality System Regulation
- ISO 13485:2016 – Medical Device QMS
Key Documentation Includes:
- Design History File (DHF) – compiled at the end of design phases for audits
- Device Master Record (DMR) – extracted for routine use & tech transfer
- Device History Record (DHR) – demonstrates compliance in routine production
- Medical Device File – required by ISO 13485:2016
The complexity of design controls depends on product design and intended use. Operon Strategist ensures Algerian manufacturers establish a robust QMS, reducing risks of FDA 483s and customer complaints.
Drug-Device Combination Products: FDA Guidance
The FDA defines combination products as those combining drug, device, biologic, or multiple categories.
Examples include:
- Prefilled syringes
- Topical product applicators
- Drug-eluting stents
Regulatory Requirements:
- Adequate design & development activities
- Compliance with ISO 13485:2016 and 21 CFR Part 820
- Documentation to prove safety, efficacy, and compliance
Improper design and development controls are a major cause of FDA 483 observations. Our consultants ensure your process is fully compliant.
EU MDR & CE Marking for Drug-Device Combination Products
Under EU MDR 2017/745, combination products are classified as:
🔹 Integral DDCs
Drug + device combined into one inseparable unit.
Examples:
- Pre-filled syringes, pens, injectors
- Drug-releasing intra-uterine devices
- Dry powder inhalers (non-refillable)
- Implants with medicinal release
🔹 Non-Integral DDCs
Drug and device are distinct but co-packaged or cross-labeled.
Examples:
- Oral dosing devices (cups, spoons, syringes)
- Refillable pens/injectors
- Reusable inhalers and spacers
- Pumps for drug delivery
We help Algerian manufacturers achieve EU MDR compliance and CE Marking approval, ensuring smooth EU market access.
CAPA Management for Combination Products
Corrective and Preventive Action (CAPA) ensures product quality, compliance, and continuous improvement.
Our CAPA consulting includes:
- Identifying & investigating quality issues
- Implementing corrective actions
- Preventing recurrence with root cause analysis
- Maintaining compliance documentation
This ensures products:
- Meet user needs & intended use
- Fulfill regulatory & technical requirements
- Can be consistently manufactured & installed
Tools for Archiving & Compliance in Combination Products
We support manufacturers in establishing design and development procedures:
- Define design input requirements
- Create design outputs to final specs
- Conduct design verification & validation
- Transfer outputs into production
- Maintain DHF, DMR, and DHR
- Ensure controlled design changes
This structured approach guarantees compliance throughout the product lifecycle.
Ready to Bring Your Combination Product to Market? Contact Us for a Tailored Compliance Strategy.
Why Choose Operon Strategist?
15+ years of consulting expertise in drug-device combination products
Deep knowledge of FDA (21 CFR), EU MDR, and ISO 13485
End-to-end support – from design & documentation to approval & audits
Trusted by global medical device & pharmaceutical manufacturers
Accelerate your drug-device combination product compliance in Algeria withOperon Strategist.
Contact us today at enquiry@operonstrategist.com
FAQ'S
Why should I hire a Drug-Device Combination Product Consultant in Algeria?
Hiring a consultant helps you avoid regulatory delays and compliance risks. At Operon Strategist, we provide expert guidance on FDA 21 CFR, EU MDR, and ISO 13485 compliance, ensuring faster approvals and cost savings in product development.
What is the biggest regulatory challenge for drug-device combination products?
The biggest challenge is meeting both drug GMP (21 CFR 210/211) and medical device QMS (21 CFR 820) requirements at the same time. Our team simplifies this dual compliance by building a strong Quality Management System (QMS) customized for Algerian manufacturers.
How can Operon Strategist speed up my product approval?
We manage the entire process—design control, CAPA management, documentation, and CE Marking support. This structured approach reduces errors, prevents regulatory rejections, and accelerates your entry into local and global markets.