Treatments
Medical Device Engineering
Design, prototyping, and validation of Class I–III devices with full documentation aligned to ISO 13485 and FDA 21 CFR Part 820 standards.
Cosmetic Formulation
Clinical skincare development from concept to compliant manufacturing, including stability testing, claims substantiation, and INCI specification.
Consumer Insight & Strategy
Mixed-methods research, ethnographic interviews, and category audits that translate patient and consumer behavior into actionable product strategy.
Regulatory Affairs
End-to-end submission support spanning 510(k), CE Marking, MDR transition, and cosmetic product notification dossiers across global jurisdictions.
Manufacturing Transfer
Process scale-up, supplier qualification, and technology transfer programs engineered to preserve quality, yield, and clinical performance.
Market Entry & Compliance
Launch readiness audits, post-market surveillance frameworks, and PMS/PMCF planning for medical and cosmetic portfolios entering regulated markets.
The Procedure
Discovery & Audit
We assess technical, regulatory, and commercial baselines, mapping gaps against target markets and user requirements.
Concept & Feasibility
Cross-functional workshops define claims, risk profiles, and design inputs that anchor development to clinical and commercial evidence.
Development & Validation
Iterative design, verification testing, and clinical evaluation occur in parallel with regulatory drafting and supply readiness.
Launch & Lifecycle
We shepherd submission, scale-up, and post-market activities, ensuring traceability from first concept to ongoing surveillance.
Why Choose Us
ISO 13485 Aligned
Every engagement operates under a certified quality management system with full design history file traceability.
Multi-Jurisdiction Filing
Active experience with FDA, EMA, MHRA, PMDA, and TGA submissions across medical and cosmetic categories.
Senior Practitioner Teams
Engineers, scientists, and strategists with eight-plus years of regulated industry experience on every project.
Clinical Evidence Generation
In-house biostatistics, usability engineering, and literature review capabilities for defensible claims.
Client Stories
Dogenso brought an editorial precision to our device development that cut our regulatory cycle by four months without compromising scientific rigor.
Their consumer insight practice reads markets with clinical clarity — every recommendation came backed by evidence we could defend to our board.
Begin a compliant development cycle
Schedule a discovery consultation to map your medical, cosmetic, or consumer insight initiative against regulatory and commercial priorities.
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