OEM/ODM complet pour dispositifs médicaux domestiques
De la définition produit au produit certifié sous votre marque : conception, moules, enregistrement réglementaire, preuves cliniques, fabrication et logistique.
Four services, one programme
- Research and regulatory: product preliminary research, CRO services, clinical trials, testing and certification.
- Design and engineering: appearance, structural, brand and packaging design; electronics, embedded and mobile software development; prototype and performance testing.
- Manufacturing: mould design and development, in-house injection moulding, assembly, packaging and inspection.
- Logistics and finance: medical-device-compliant warehousing, import/export customs handling, and supply-chain finance to improve your working capital turnover.
How a programme runs
- 1. Requirement review — target market, channel, price band and regulatory route.
- 2. Product definition — select a platform from the catalogue or scope a new one.
- 3. Industrialisation — tooling, packaging artwork, firmware and app configuration.
- 4. Verification — performance, safety and EMC testing with documented results.
- 5. Regulatory submission — FDA, EU MDR, NMPA or your national registration, supported by our technical file.
- 6. Production and delivery — ramp from pilot lots to volume, with export documentation.
Commercial terms
| Item | Detail |
|---|---|
| Lead time | 3-15 days for core components, supported by strategic chip stock |
| Order volume | Hundreds to hundreds of thousands of units |
| Customisation | Cuff, housing, display, language pack, app skin, packaging and instruction manual |
| Regulatory support | FDA, EU MDR CE, NMPA, plus CFS and FCC documentation |
| Tooling | Own mould shop — tooling cost and ownership agreed per project |
Intellectual property
We hold 23 patented technologies in infrared sensor temperature measurement and photoelectric physiological monitoring. Tooling and product IP ownership is agreed in writing at project start — we do not sell a customer-specific design to another customer.
What is the minimum order quantity?
Can you support registration in our country?
Do you do private label?
How do we start?
Réseau de fabrication
Réseau de production « 2+1 » sur trois régions
Quatre sites, un même standard qualité — production certifiée BPF à Shenzhen, composants clés localisés au Vietnam et un nouveau site à Zhongshan en construction.
Ligne de production numérique
Chaque ligne fonctionne avec un tableau kanban numérique
Chaque ligne d'assemblage est pilotée par un tableau kanban numérique : l'avancement des commandes, la production horaire, le temps de cycle et les données qualité en ligne sont affichés en temps réel au poste. Les matières sont appelées poste par poste, les anomalies déclenchent instantanément des alertes andon, et les mêmes enregistrements alimentent la traçabilité des lots — les marques peuvent ainsi auditer les données de ligne à tout moment, pas seulement les unités finies.
Design industriel et packaging, en interne
Demander un devis
Indiquez votre marché cible, le volume prévu et le calendrier. Nous répondons sous un jour ouvré.
Dernières actualités et salons
Salons, jalons de certification et actualités de l'entreprise.
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