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ECURAC

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ECURAC | ecurac.com Reviews

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regulatory consultants,medical devices,fda,510(k),pma,sfda,ce,mdd,ivdd,aimdd,iso 13485,part 820,qsreg,qsit

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Services :: ECURAC

https://www.ecurac.com/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. The main services include:. Medical Device Registration Advisory. CE certification and ISO 9001, ISO 13485 system certification. US FDA 510(k) and GMP quality system requirements. ECURAC - EU / China / US Regulatory Affairs Consultants.

2

Write to Us :: ECURAC

https://www.ecurac.com/write-to-us

ECURAC - EU / China / US Regulatory Affairs Consultants. 1 805 570 6135. 105;nfo@ecurac.com.

3

About Us :: ECURAC

https://www.ecurac.com/about-us

At ECURAC, we believe that each medical device is unique. Our approach is to communicate with regulatory agencies, to identify the requirements applicable to your unique device and to communicate them to each regulatory agency and to develop the regulatory strategy that works best for your specific product in order to offer you the most accelerated market approvals. ECURAC - EU / China / US Regulatory Affairs Consultants. 1 805 570 6135.

4

ECURAC

https://www.ecurac.com/home

Welcome to ECURAC Consulting Group! Looking for a fast and efficient way to register and market your medical devices in Europe, China and United States? Tired of ambiguous regulation guidelines and endless supplementary requests from regulatory agencies? ECURAC Consulting has the solution. Our experienced regulatory experts throughout our global network are specialized to handle your regulatory issues. Contact us today. ECURAC - EU / China / US Regulatory Affairs Consultants. 1 805 570 6135.

5

News :: ECURAC

https://www.ecurac.com/news-

In order to strengthen the management of medical device clinical trial, to protect the rights of the subjects, to standardize the trial operations and to obtain authentic, scientific, reliable and traceable clinical findings, the China Food and Drug Administration (CFDA) released. Mdash;————. China cancelled CCC Certification of medical devices. Mdash;————. SFDA is now China Food and Drug Administration (CFDA). Mdash;————. FDA Issues New cGMP Combination Products Rule. The FDA has issued a final rule on ...

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ECURAC

Welcome to ECURAC Consulting Group! Looking for a fast and efficient way to register and market your medical devices in Europe, China and United States? Tired of ambiguous regulation guidelines and endless supplementary requests from regulatory agencies? ECURAC Consulting has the solution. Our experienced regulatory experts throughout our global network are specialized to handle your regulatory issues. Contact us today. ECURAC - EU / China / US Regulatory Affairs Consultants. 1 805 570 6135.

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