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Fabricante de dispositivos médicos busca un productor alemán con sistema QM e ISO 13485

Resumen

Tipo:
Demanda Tecnológica
Referencia:
TRSG20161103001
Publicado:
24/11/2016
Caducidad:
24/11/2017
Resumen:
Una empresa de Singapur especializada en diseñar dispositivos médicos busca un fabricante por contrato de dispositivos médicos en Alemania con el fin de producir un dispositivo electrónico conforme a la directiva europea 93/42/EWG para sus clientes alemanes. El dispositivo médico consiste en un módulo de sensores de ECG que se coloca en el tórax, un microcontrolador, conexión Bluetooth y periféricos. La empresa, que vende sus productos a agencias internacionales, como la Organización Mundial de la Salud, busca pymes y multinacionales de 251 a 500 empleados con el fin de establecer acuerdos de fabricación o cooperación técnica.

Details

Tittle:
Seeking electronic medical device manufacturer from Germany with QM-System, ISO 13485 capabilities
Summary:
A Singapore medical device design company is seeking a medical device contract manufacturer in Germany to produce a medical electronic device for its clients in Germany.

The contract manufacturer should possess design-for-manufacturing capabilities in Germany for a CE certified 93/42/EWG medical electronic device, for sales in Germany.

The Singapore company is seeking to work with SMEs of any sizes or MNEs (251-500) for a manufacturing or technical cooperation agreement.
Description:
The Singapore company provides medical equipment and medical consumables to Southeast Asia countries. It sells products to International agencies such as the World Health Organization.

The requirements for the tech request are as follows:

1) The manufacturer shall have a QM-System with ISO 13485 certification and preferably provides 93/42/EWG certification consultancy and services, and design-for-manufacturing capabilities.

2) The electronic device to be manufactured consists of a chest-worn ECG sensor module and a sub-component consisting of microcontroller (MCU), bluetooth connectivity and peripherals.

3) The medical device has been designed with ready build-of-materials (BOM), schematics, firmware and software developed. However, some development and enhancement may be necessary for 93/42/EWG conformity.

The Singapore company is seeking to work with SMEs of any sizes or MNEs (251-500) for a manufacturing or technical cooperation agreement.
Technical Specification or Expertise Sought:
Electronic manufacturer with QM-System with ISO 13485 certification and preferably provides 93/42/EWG certification consultancy and services

Partner sought

Type and Role of Partner Sought:
The type and size of partner sought includes:
- 251-500 MNE
- SME of any sizes

The type of partnership considered include:
- Manufacturing agreement
- Technical cooperation agreement

The partner would be a medical electronics contract manufacturer with the relevant certifications and expertise to fulfil this tech request as provided in the Description.

Client

Type and Size of Client:
Industry SME <= 10
Already Engaged in Trans-National Cooperation:
Si
Languages Spoken:
English