Medical Device Research & Development

Production & Product File

Production and product files are prepared according to ISO:13485 standard or in accordance with the customer requirements.

The documentation is created throughout the entire development process and enables building the DHF – Design History File – and the DMR – Device Master Record.

The production file consists of the full specification for producing the product according to the required quality processes. It enables the customer to examine multiple manufacturers and to manufacture the product almost anywhere.


The main components of the product file are:

  • Documentation – a summary of the thought and engineering processes, documentation of drawings and tests performed in the development course, such as temperature range design tests, testing of resistance to forces and stresses, ability to integrate with other products, in-tissue tests, documentation of validation processes, sterilization process, packing, biocompatibility, etc.
  • Bill of Materials (BOM) – a compilation of all the product components, enabling locating the most suitable supplier according to parameters such as costs, required materials and unique technological capabilities required for the production.
  • Assembly and Production Instructions – detailed documentation of the assembly processes including visual documentation, criteria for testing and approval, bills of quantities, the appropriate environment for installation and assembly and safety.
  • Packaging – details of packaging developed at Integer (support card, blisters, pouches, etc.), including details of compatibility with required sterilization processes, impermeability tests, and validation of the packaging.
  • Sterilization – a detailed description of the required sterilization processes, including potential providers. Integer obtains extensive knowledge in the field of sterilization (ETO, Gamma rays, Beta rays, autoclaves etc.) and is closely familiar with service providers.


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