Technical documentation section 3. Design and manufacturing:

3.1 Description of design process including R&D site(s) identification

This section provides a detailed overview of the design and development process implemented for the medical device. The design process follows a structured approach aligned with the requirements set out in Annex II of Regulation (EU) 2017/745 (MDR), and is integrated into the manufacturer’s Quality Management System.

General design and development approach

The development of the изделие is managed through a defined lifecycle model, starting from the identification of user needs and regulatory requirements, progressing through concept and feasibility, detailed design, verification, and validation, and concluding with design transfer to production. Risk management activities are performed throughout the design process, as outlined in the risk management file.

Design inputs are documented and reviewed for adequacy and completeness. Design outputs are validated against inputs and verified through testing and evaluation. Traceability is maintained between inputs, outputs, verification, validation, and risk management documentation.

Design reviews and change control

Formal design reviews are conducted at key stages of the project to ensure that the design remains in alignment with intended use and regulatory compliance. All changes to design specifications are managed through a documented change control procedure within the QMS.

Identification of R&D site(s)

The design and development activities are carried out at the following R&D location(s):

• Primary R&D Center: Name, full address, country
• Secondary R&D Support Site (if applicable): Name, full address, country

All R&D sites operate under the same QMS and are subject to internal audits and management oversight to ensure compliance with MDR and ISO 13485 standards. Collaboration between multiple sites, if applicable, is documented and clearly assigned within project management files.

Design documentation and records

All records generated during the design and development process are maintained in accordance with document control procedures. These records include design inputs and outputs, verification and validation reports, risk assessments, and design review minutes. The documentation ensures full traceability and supports the demonstration of conformity with the General Safety and Performance Requirements (GSPRs) under MDR.