Services

We deal with complicated issues that require an extraordinary blend of technical, legal and industry expertise. We are professionals who help organizations with practically any issue throughout the licensing, approval and registration sector for medical devices.

ECURAC Medical Devices Registration Consulting is an international company specialized in the U.S. FDA 510(k), CMDCAS / Canada, Russia and Australia TGA, EU CE-Mark (MDD, IVDD, PPE) certification and ISO 9001, ISO 13485 system certification. Senior experts in regulatory consulting offer accurate knowledge about the requirements of various laws and regulations in different countries for  medical devices. The company's biggest advantage are the local experts for an effective communication with government authorities and institutions. 

The main services include: 

• Medical Device Registration Advisory 

• Medical Devices Writing 

• Medical Device Testing 

• CE certification and ISO 9001, ISO 13485 system certification

• U.S. FDA 510(k) and GMP quality system requirements

If you would like to inquire about our services please feel free to contact us by one of the methods listed on our Contact Us page.

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ECURAC医疗器械注册咨询公司是一个国际化的公司,专门从事美国FDA(510K)， 加拿大CMDCAS，俄国以及澳大利亚

TGA等国家的医疗器械注册咨询，同时包括欧盟CE（MDD、IVDD、PPE）认证及ISO9001、ISO13485体系认证和授权代表服务，我公司拥有一支熟悉医疗器械专门从事法规咨询注册资深专家，帮助企业准确掌握不同国家对医疗器械各种法律、法规的要求，公司最大的优势是咨询专家来自当地专家从而有效的以政府或机构进行沟通。
主要服务包括：

• 医疗器械注册咨询

• 医疗器械文件撰写

• 代理医疗器械检测

• CE认证及ISO9001、ISO13485体系认证和授权代表服务

• 美国FDA510（k）及GMP质量体系认证和授权代表服务

We are experts for US FDA regulatory requirements, identify the best approach to fulfill the rules and guide you through the complex processes.