Quality informations

QUALITY AND MARKET INTELLIGENCE - VALUES THAT ARE AT OUR FOUNDATION To anticipate market needs, To offer global solutions in accordance with the customers' needs. CUSTOMER SATISFACTION Customer satisfaction is the heart of our quality policy and corporate culture, For top quality, For unfailing safety.

Anthogyr is ISO 9001 and ISO 13485 certified; our products are CE marked according to Medical Device Directive 93/42/CEE: we are committed to constantly improve our quality control. QUALITY MANAGEMENT SYSTEM ISO 9001 ISO 13485 ISO 13485, Cover Letter Taiwan

• MANAGEMENT STATEMENT 

Click here to download our charter of commitment to quality!

•  REGULATORY AFFAIRS - PRODUCT CERTIFICATION

 Our Regulatory Affairs Department is at your service for any country specific registration.
Anthogyr currently meets the requirements of the most demanding countries in terms of certification, technical files and registration required by medical authorities, with the help of local legal representatives/distributors : 

EUROPE	CE marking	Certificates: Appendix II, Appendix V Im and Appendix V Is
USA	FDA registration	Click here !
JAPAN	MHLW accreditation	Accreditation certificate of foreign medical device manufacturer
RUSSIA	Certificate of conformity « GOST-R »	Product license
CHINA	SFDA approval	Product license
TAIWAN	BOPPA approval
BRAZIL	ANVISA registration

For more informations, click here !

If you need any further information, please contact our Regulatory Affairs Department.