I.D.M.S.
Integrated Development & Manufacturing Service
Winnoz offers Integrated Development & Manufacturing Service, specializing in medical device development from design to compliance with ISO 13485, QMS, and FDA standards, backed by 10+ years of experience.
Customized Products to Fit Your Requirements
We Offer the Following Three Plans
Fingertip Blood Collection Device Customization
- Customization of appearance (color, labeling).
- Cartridge adjustments to fit specific blood collection tubes.
- And more…
LAMP Molecular Testing Device Customization
- Adaptation to different reagent tubes.
- Software (GUI) adjustments to align with experimental requirements.
- Customization of appearance (color, labeling) and UI modification for optimal operation.
- And more…
Tailor-Made Medical Device
- ODM (Original Design Manufacturer) services.
- Establishment of ISO documentation and arrangement of certification testing.
- Mass production solutions.
- And more…
Why Choose Winnoz?
✓ Advanced Medical Technology & R&D Expertise
A multidisciplinary team consisting of biomedical researchers (specializing in molecular biology), mechanical engineers, and software/firmware developers, along with experts in biochemistry, chemistry, medicine, intellectual property, mechanism engineering, software engineering, and sales and marketing.
✓ Comprehensive Product Development Capabilities
- End-to-end solutions: Design → Manufacturing → Testing & Validation → Mass Production → Packaging.
- Extensive experience collaborating with reagent manufacturers.
✓ Regulatory Compliance & Certifications
- Expertise in international medical device regulations and registrations (CE, FDA).
- Certified ISO 13485 Medical Device Quality Management System.
✓ Flexible & Scalable Manufacturing
- Small-batch, high-mix production to large-scale mass
- Agile production scheduling for fast turnaround times.
✓ Strict Quality Control & Risk Management
- Rigorous quality assurance processes to ensure product reliability and compliance.
Tailored Solutions, Your Next Project Partner
Welcome RFQs and look forward to collaborating
