Your device, developed and built on our line.
We design, engineer and mass-produce wearable temperature sensing devices in-house. As a CDMO partner, that entire capability — R&D, firmware, tooling, licensed production — works on your product.
Medical device CDMO capability, end to end
Product development
Wearable sensor hardware, low-power firmware and companion software engineering — the same team behind the P20 platform.
Licensed manufacturing
In-house production under medical device manufacturing license 粤食药监械生产许可 20224699 and an ISO 13485 quality system.
Regulatory experience
We've taken a Class II medical device through NMPA registration — and support partners through their own regulatory paths.
Calibration & QC
Unit-level sensor calibration and validated QC processes, built for clinical-accuracy products.
From specification to mass production
NDA & requirements
Your specification, target markets and regulatory context — assessed for feasibility and cost.
Development & samples
Engineering builds and iterates; you receive functional samples for validation.
Tooling & pilot run
Production tooling, process validation and a pilot batch under the quality system.
Mass production
Scheduled production with QC reporting, packaging and export logistics.
CDMO, OEM or ODM — which fits your project?
- OEM: our existing P20 products under your brand — fastest to market
- ODM: our platform, modified to your requirements — balanced speed and differentiation
- CDMO: your specification, our development and manufacturing — maximum differentiation
What a medical device CDMO partnership involves
Medical device CDMO vs simply outsourcing assembly
A contract assembler builds to a finished design; a medical device CDMO gets involved earlier, contributing engineering, firmware and regulatory experience alongside manufacturing capacity. As a CDMO partner, P20's own product development team — the group behind the P20 platform itself — works on your specification, not just a factory floor executing someone else's finished blueprint.
Wearable device contract manufacturing on a licensed line
Manufacturing under medical device manufacturing license 粤食药监械生产许可 20224699 and an ISO 13485 quality system means production runs under documented process controls appropriate for a regulated device, not a general consumer electronics line adapted for medical use. For a wearable specifically, this includes the calibration and QC processes needed to support clinically meaningful accuracy claims.
Contract development for medical sensors: what's actually included
Development capability spans hardware design, low-power firmware engineering and companion software — built by the same team responsible for P20's own sensor, app and platform. This means a CDMO engagement isn't limited to manufacturing an already-finished design; it can start as early as a specification and feasibility assessment.
Choosing between OEM, ODM and CDMO for your project
OEM suits a partner who wants an existing P20 product under their own brand with minimal changes — the fastest path to market. ODM fits a partner who needs the platform modified to specific requirements. CDMO is the right fit when a partner has their own specification and needs full development plus manufacturing from that starting point, offering the most differentiation but requiring the most upfront scoping.
Medical device CDMO questions
What's the difference between a CDMO and a standard contract manufacturer?
A CDMO contributes product development — engineering, firmware, regulatory experience — in addition to manufacturing, whereas a standard contract manufacturer typically only builds a design you provide fully finished.
Can P20 develop a wearable medical sensor from our specification?
Yes. Our CDMO engagement path starts with an NDA and requirements review, followed by development, functional samples, tooling and a pilot run before mass production — starting from your specification rather than an existing product.
What quality certifications does your manufacturing line hold?
Production operates under an ISO 13485 quality management system and medical device manufacturing license 粤食药监械生产许可 20224699, on the same line that manufactures the P20 platform.
Do you support regulatory registration for a custom-developed device?
We bring experience from taking P20 through NMPA Class II registration and support partners through their own regulatory paths, though specific registration responsibilities are scoped per project and per target market.
How do I know whether I need OEM, ODM or CDMO?
OEM fits rebranding an existing P20 product; ODM fits modifying our platform to your requirements; CDMO fits developing a new device from your own specification. Our team can help determine the right fit during an initial scoping call.