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Howard Hao

Position：Technical director

Experience introduction：

13 years experience in CE certification in Eu, 2 years experience in UK certification body.

11 years of focus on medical device certification consulting, familiar with domestic and foreign medical products related laws and regulations and system requirements.

Mainly engaged in certification consulting includes:

1. CE of European Medical Devices

· Prepared CE technical documents for passive products, active equipment and IVD products, and design Dossier for class III products;

2. Prepared registration documents of FDA 510(K), Canada CMDR, Brazil ANVISA, Australia TGA, Japan PMDA, etc.

3. (EN) ISO 13485 system, MDSAP single system, and the establishment of American QSR820, Brazilian RDC ANVISA 16/2013, And Japanese J-GMP/J-QMS.

International Projects

China Project

About Us

Database

400-0569-812

Database

400-0569-812