ISO 13485 implementation

Cratia provides professional medical device registration (market authorization, conformity assessment, notification) services in 12 countries and the Eurasian Economic Union (EAEU):

Azerbaijan Georgia Moldova Turkmenistan
Armenia Kazakhstan Mongolia Uzbekistan
Belarus Kyrgyzstan Tajikistan Ukraine

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.

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.

We are ready to perform the following works:

  • Consulting and planning; 
  • Determining the applicable harmonized standards, organization of technical tests in accredited laboratories; 
  • Stability testing in accredited laboratories; 
  • Conducting nonclinical studies in accredited laboratories (EN ISO 10993); 
  • Writing of risk analysis (management plan and risk file) in accordance with relevant standards; 
  • Sterilization validation (EN ISO 11135, EN ISO 11137); 
  • Labeling and instructions for use (user manuals); 
  • Medical writing of the clinical assessment (MedDev 2.7.1 rev 4); 
  • Filling in the Essential Requirements Checklist; 
  • Assembling of the Technical file. 

The content of the Technical documentation will vary in each case depending on the type of the device, the risks involved in its manufacture, installation, operation and maintenance and on the time during which the product is on the market.

That is why there is no universal guide for creating of the Technical Files. In our activities, we are based on the international practice of creating such documents, guided by the European and national regulatory documents.

 

Cratia performs works on editing, filling and translation of the necessary parts of the Technical File. We have the necessary experience in working with international document formats and our own developed approach in creating and maintaining technical documentation of the manufacturer.

To start cooperation or get advice, please contact us by phone: +38 044 361-48-28, +38 044 221-71-29, by e-mail: info@cratia.ua, or visit our office.

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(name, formulation, dose and route(s) of administration, date of therapy start)