Case 1: Medical Equipment Manufacturing — Design Documentation + TD for a Line of Ultrasound Machines (Moscow)
Brief:
A Russian developer creates ultrasound machines. To localize production and obtain subsequent certification, a full design documentation/td is required.
What was accomplished:
- Development of 3D models in CREO + drawings according to GOST standards;
- Assembly drawings and connection diagrams (DD);
- Specifications and tables for purchased parts;
- Assembly process instructions, process instructions for machining housings;
- Preparation of technical data sheets, operating instructions, and specifications for registration with Roszdravnadzor.
Result:
The product successfully passed testing and registration as a medical device. The production series was launched in Zelenograd. All documentation is included in the company's electronic archive (in accordance with GOST 2.501).
Case 2: Machine-Building Plant (St. Petersburg) — Implementation of Unified System for Design Documentation (USKD) and Unified System for Documentation (ESTD) for Machine Upgrade
Task:
Develop a set of design documentation and process documentation for upgrading a 16K20 CNC lathe.
Stages:
- Collection of original drawings (partially lost — restored upon completion);
- 3D scanning of basic components;
- Design of new components: electrical cabinet, drive, control panel;
- Development of design documentation in accordance with the Unified System for Design Documentation (GOST 2.102–2.113);
- Preparation of flow charts and operation maps in accordance with the Unified System for Design Documentation (GOST 3.1105, 3.1404);
- Document verification with the Quality Control Department and the production department.
Result:
The upgrade was successful, a batch of 12 units was launched, and the machine received TR CU certification. Part machining time was reduced by 30%, and the staff was trained in the process.
