Turning ideas into life-saving MedTech solutions is complex and highly regulated. At Qualentra Global, we streamline this journey with end-to-end R&D services that accelerate development, reduce risk, and align innovation with market and regulatory needs.
- Problem Definition & Clinical Need Assessment
- Technology Feasibility & Proof of Concept
- Prototyping & Functional Testing
- Verification and Validation Support
- Regulatory-aligned Documentation
- IP Strategy & Patent Filing Support
End-to-End R&D Lifecycle in MedTech (6 Key Stages)
Market Research
Deep dive into unmet medical needs with KOL engagement and market research.
Conceptual Design & Feasibility Study
Brainstorming, technology scouting, and risk analysis to assess viability.
Prototyping & Preclinical Evaluation
Rapid prototyping with iterative feedback, including preclinical safety testing.
Design Freeze & Verification
Locking down specifications, DFM (Design for Manufacturing), and bench testing.
Regulatory Alignment & Documentation
Technical file generation, ISO 13485 design controls, and risk management.
Go-to-Market Readiness & Sustenance
Commercial strategy alignment, Manufacturing support, and Periodic product upgrades
100%
Scalable & Manufacture-Ready Designs
30%
Faster Concept-to-Prototype Conversion
90%
First-Pass Regulatory Documentation Success
Frequently asked questions
We work with both. Our modular approach allows early-stage startups to get focused support while offering mature companies a flexible R&D extension arm.
We assist through clinical validation planning and connecting with CROs and hospital networks. While we don’t conduct trials ourselves, we prepare the documentation and protocols needed for necessary approvals.
Our R&D process is tightly integrated with ISO 13485 design controls and documentation standards. Each phase includes regulatory checkpoints, risk assessments, and traceability matrices to ensure full compliance.