Electronic instructions

Most medical devices are accompanied by instructions necessary for safe use. If the manual is mandatory or provided by the manufacturer, it must be supplied with each product.

Thus, the medical device industry generates a large number of paper instructions, some of which may be redundant for the end user, for example, in the case of regular deliveries of identical products to a medical institution or laboratory. At the same time, it damages the environment and increases the final cost of the product.

In the modern world, information in paper form has become an archaism – it is inconvenient to store it, searching for the necessary data takes time, access can be limited, and it is completely impossible to update the printed text.

This project provides an opportunity for manufacturers of some medical devices to switch from paper to electronic instructions, and for users to receive a paper version free of charge if necessary.

We expect that our project will allow:

  • reduce the load on the environment;
  • increase the overall safety of medical devices;
  • improve access to information on effective and safe use and its updating;
  • reduce the cost of products for the consumer by reducing costs;
  • to simplify the processes of labeling and providing products on the market;
  • improve compliance with regulatory requirements.

This decision was developed taking into account the requirements of GHTF/SG1/N70:2011 and world practice, responses of the Ministry of Health of Ukraine and the State Service of Medicines and Drug Control of Ukraine regarding the use of electronic instructions.

We are open to cooperation with manufacturers of medical devices and their authorized representatives in Ukraine, as well as with any interested organizations and individuals.

This project is commercial. We provide the necessary consultations, develop and sell all actions for the transition to electronic instructions, conduct or assist with the necessary legal and regulatory issues.

We provide preliminary consultations free of charge, call us by phone +38 (068) 064-78-31, +38 (044) 223-61-67, or write to the e-mail info@cratia.ua, or come to a meeting directly at our office.