{"id":173,"date":"2019-10-09T17:58:18","date_gmt":"2019-10-09T14:58:18","guid":{"rendered":"http:\/\/cratia.com\/?p=173"},"modified":"2020-11-18T16:29:47","modified_gmt":"2020-11-18T14:29:47","slug":"razrabotka-i-vnedrenie-iso-13485","status":"publish","type":"post","link":"https:\/\/cratia.com\/en\/uslugi\/mediczinskie-izdeliya-i-tehnika\/razrabotka-i-vnedrenie-iso-13485\/","title":{"rendered":"ISO 13485 implementation"},"content":{"rendered":"

<\/p>\n

Cratia provides professional medical device registration (market authorization, conformity assessment, notification) services in 12 countries and the Eurasian Economic Union (EAEU)<\/a>:<\/span><\/p>\n\n\n\n\n\n
Azerbaijan<\/span><\/a><\/td>\nGeorgia<\/span><\/strong><\/a><\/td>\nMoldova<\/span><\/a><\/td>\nTurkmenistan<\/span><\/a><\/td>\n<\/tr>\n
Armenia<\/span><\/a><\/td>\nKazakhstan<\/span><\/a><\/td>\nMongolia<\/span><\/a><\/td>\nUzbekistan<\/span><\/a><\/td>\n<\/tr>\n
Belarus<\/span><\/a><\/td>\nKyrgyzstan<\/span><\/a><\/td>\nTajikistan<\/span><\/a><\/td>\nUkraine<\/span><\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

The Head office is located in Ukraine, the country with the most developed and high regulatory requirements. In 2013, Ukraine implemented Technical Regulations for medical devices based on Directives 93\/42\/EEC, 98\/79\/EC and 90\/385\/EEC. We have successfully applied the many years of experience and knowledge gained on the national market to scale services in other countries. Our experts have deep knowledge of the national legislation of each country, specific requirements for registration materials and approval procedures, use professional terminology and monitor all changes.<\/span><\/p>\n

Since 2014, we have been developing the Technical Documentation for medical devices for national and international manufacturers. We determine the necessary standards, scope of testing and choose the accredited laboratories, develop documentation on risk management and clinical assessment, fill and assemble the Technical File. The documentation developed with our assistance obtain approvals both in national markets and in the EU.<\/span><\/p>\n

We are ready to perform the following works:<\/span><\/p>\n