Development of Technical Conditions and Process Regulations
Technical Regulations (TU) is a document that establishes the technical requirements that a particular product, material, substance, and the like must satisfy. In addition, the TU must specify the procedures by which you can install, meet these requirements.
Specifications are a technical document that is developed by decision of the Developmenta (manufacturer) or upon the request of the customer (consumer) of the product. Technical specifications are an integral part of a set of design or other technical documentation for products, and in the absence of documentation they should contain a full range of requirements for products, their manufacture, control and acceptance. The composition, construction and design of technical conditions must comply with the requirements of GSTU, GOSTs and other regulatory documents operating in Ukraine.
Process regulations is a document that establishes the technological regime, the procedure for carrying out technological process operations, ensures the production of products of appropriate quality and safe operating conditions of production.
Private enterprise "POLITOKS" has been working in the market of medical devices for more than 20 years, technical experts have extensive experience in the field of Conformity Assessment and have the necessary knowledge and ability to carry out the full range of work on the development and writing of technical conditions and process regulations .
We will be glad to cooperate!