Technical specifications of medical devices

Technical specifications is a technical document that is designed by decision of the (manufacturer).Technical specifications are a 
document that is prepared in full accordance with state standards and must comply with GOST, in Russian Federation 
Technical specifications known as Certification of non-standardized products and is carried out in accordance with core state 
standards to meet the requirements of state standards for similar products by purpose.

Technical specifications should contain an introductory section and other sections arranged in the following order: technical 
requirements, safety requirements, environmental requirements, acceptance rules, methods of control, transportation and storage, 
operating instructions, the manufacturer's warranty.

Specialists the company "Sertigrad" offers services for the development of technical specifications for medical devices and food 
products,consumer goods, low-voltage equipment an so on.

The following sections should be included in the TS:
- technical requirements; 
-safety requirements; 
- environmental protection requirements; 
-acceptance rules; 
-methods of control (testing); 
-operating instructions, including requirements for storage, transportation and disposal of the product;
- manufacturers' guarantees.
Technical specifications (TS)- confirms the degree of quality of the product,: in the process of direct manufacture, control
of the procedure, ensuring compliance with safety and environmental requirements, movement, storage and consumption.

What is the use of TS?
To obtain a declaration of conformity or a certificate for any product from an accredited certification body, the manufacturer must 
have GOST or TS

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