medinOne

一体化CDMO服务

medinOne是密尔医疗在CDMO领域
全新推出的系统级服务解决方案
medinOne is a new system-level
service solution launched by menovex in CDMO
medinOne是密尔医疗
在CDMO领域全新推出的
系统级服务解决方案
medinOne is a new
system-level service solution
launched by menovex in CDMO
密尔医疗
CDMO一体化服务
medinOne
CDMO service
密尔具有多场景医用特种激光器、电源模块、电控模块、人机交互系统、治疗端耗材等核心部件的研发能力,
同时具备完善的医疗级激光装备设计开发经验、质量管理体系、售后支持方案。
专设ODM团队为行业伙伴提供医疗级激光模块/系统一站式服务:
覆盖产品设计开发、型检支持、注册与法规支持、样机测试、批量制造、售后客诉处理等。
严格执行ISO13485、QSR820、GMP质量管理体系,可配合药监部门体系考核,
全生命周期保障,提供安全、有效的ODM产品。
menovex has the R&D capability of core components such as multi-scenario special medical lasers, power modules,
electronic control modules, man-machine interactive systems, therapeutic consumables, and is also experienced in the design and development of medical laser equipment,
with comprehensive quality management system and after-sales support programs.
menovex dedicated ODM team provides one-stop service for medical-grade laser modules/systems, product design and development, type test support,
registration and regulatory support, prototype testing, batch production, after-sales service and so on. We implement strictly ISO13485,
QSR820 and GMP quality management systems, providing safe and effective ODM products.
密尔具有多场景医用特种激光器、电源模块、电控模块、
人机交互系统、治疗端耗材等核心部件的研发能力,
同时具备完善的医疗级激光装备设计开发经验、
质量管理体系、售后支持方案。
专设ODM团队为行业伙伴提供医疗级激光模块/系统一站式服务:
覆盖产品设计开发、型检支持、注册与法规支持、样机测试、
批量制造、售后客诉处理等。严格执行ISO13485、QSR820、
GMP质量管理体系,可配合药监部门体系考核,
全生命周期保障,提供安全、有效的ODM产品。
menovex has the R&D capability of core components
such as multi-scenario special medical lasers,
power modules, electronic control modules,
man-machine interactive systems, therapeutic consumables,
and is also experienced in the design and
development of medical laser equipment,
with comprehensive quality management system
and after-sales support programs.
menovex dedicated ODM team provides one-stop service
for medical-grade laser modules/systems,
product design and development, type test support,
registration and regulatory support,
prototype testing, batch production, after-sales service
and so on. We implement strictly ISO13485,
QSR820 and GMP quality management systems,
providing safe and effective ODM products.
服务流程 process
协助合作伙伴
从立项到量产的一站式服务
Assisting our partners with one-stop service
from project establishment to mass production
Assisting our partners with one-stop
service from project establishment
to mass production
了解更多 more

服务流程 service process

从需求到落地无缝对接

为国内外行业伙伴提供
全周期、系统级的激光医疗ODM服务
requirement to
implementation
为国内外行业伙伴
提供全周期、系统级的
激光医疗ODM服务
requirement to
implementation

客户初步产品需求
部分核心技术
Customers’ initial requirement

01

需求分析
技术方案提供
Requirement analysis
Technical Proposal

02

产品规格 Product specifications

设计输入 Design input

法规要求 Regulatory

质量要求 Quality

软硬件规格 Hardware &
Software Specifications

成本要求 Cost requirements

产品开发 Product development

03

1 项目计划 Project plan

质量管理计划 Quality management

风险管理计划 Risk management

测试计划 Test

设计文档要求 Requirement of
design document

2 概念设计 Conceptual design

概念设计 Conceptual design

成本估算 Cost estimation

DFMEA

DFX

3 设计开发 Design & Development

具体设计 Specific design

DFMEA

DFX

设计文档输出 Design document output

供应商选择 Vender selection

打样 Prototype

预测试 Pre-test

4 设计转移 Design transfer

供应量批准 Supply approval

设计转移 Design transfer

可追溯文档 Traceable documentation

DHF

生产测试 Production test

系统开发 System development

5 验证确认 Verification

性能测试 Performance test

可靠性测试 Reliability test

EMC测试 EMC test

安全测试 Security test

过程确认 Process confirmation

DHR

供应链管理 Supply chain management

04

验证测试确认 Verification confirmation

05

产品注册 Product Registration

06

6 形式实验注册文档 Registration document of
type test

第三方测试 3rd-Party test

注册文档 Registration documents

临床评价(实验) Clinical evaluation (Experimental)

质量系统审核 Quality system audit

注册申请 Registration application

产品量产 Mass production

07

7 小批量多品种量产 Small-batch production

质量管理 Quality control

供应量管理 Supply management

生产管理 Production management

变更管理 Change management

CAPA

持续改进 Continuous improvement

客户市场及销售 Marketing & Sales

08
定制选配 customized
多样化的定制选配方案
让你的产品更贴合使用场景
A variety of customized options to
make your products more suitable
for usage scenarios
了解更多 more

定制选配 customized

全方位定制服务

前往定制 go to customize
激光医疗设备个性化定制 laser medical equipment personalization
外设模组选配单 peripheral module selection list
显示 display
7寸、10寸、12寸触屏显示,7寸、10寸、12寸工控机 7 IN, 10 IN, 12 IN touchscreen display, 7 IN, 10 IN, 12 IN industrial computer
脚踏 foot pedals
单脚踏、双脚踏、三脚踏、按钮 single-foot pedal, double-foot pedals, thurible-foot pedals, button
物联网 internet of things
5G模块、蓝牙模组、WiFi模组 5G module, bluetooth module, WiFi module
工业设计选配单 industrial design options
人机UI Interactive UI
客户自研,一体打包 Customized comprehensive package
外壳 Housing
公立医院、家庭消费、美容院线,万向轮、辅助刹车 Public hospitals, household consumption,
beauty salons, universal wheels, auxiliary brakes
治疗手具/耗材选配单 therapeutic handpieces/consumable selection list
光纤类 Optical fibers
短针状、长针状、平头SMA耦合跳线、特殊端头SMA耦合跳线 Short pin, long pin,
flat & special end SMA fiber patch cord
固定光斑手具 Fixed Spot Handpiece
圆光斑照射、光纤夹持、特殊耦合类、含水气功能类 Circular spot irradiation, optical fiber clamping,
special coupling, water and gas function
点阵手具 Dot Matrix Handpiece
固定点阵类、可编程点阵类 Fixed lattice, Programmable Lattice
智能手具 Smart Handpiece
含RFID功能、含视觉功能、含温度传感功能、含辅助机械臂、含AI辅助机械臂 Containing RFID function, visual function, temperature sensor,
auxiliary manipulator, and AI auxiliary manipulator
冷却模组选配单 cooling module option
水冷 Water-cooled
主要适配于高功率固定激光器、压缩制冷、热交换制冷 Mainly used for high-power DPSSL laser,
compression refrigeration, and heat exchange
风冷 Air-Cooled
主要适配于中底功率固体激光、半导体激光和光纤激光器 Mainly used for medium and low power DPSSL laser,
semi-conductor laser and fiber laser
治疗激光器选配单(具体参数另行确定) Therapeutic laser options
(specific parameters to be confirmed)
短波 Short Wavelength
193/308nm、355nm、405/450/488nm、520/532nm
565/577/585nm、632/650nm、755nm
近红外 Near-infrared
810/905/940/980nm、1064/1342nm、1470/1560nm、1726nm
中红外 Mid-infrared
1940nm、2013/2100nm、2780/2940nm、3800nm
中远红外 Mid-far infrared
9.3μm、10.6μm