The requirements for medical device files in ISO 13485:2016 are an effort to create consistent operations for medical device manufacturers, and also to make their Quality Management Systems compliant with the rules of various regulatory bodies.
Manufacturers and suppliers of medical devices must manage thousands of different medical products. Therefore, it is critical that these organizations document their design and development processes, flow of manufacturing processes, records of devices, and advanced manufacturing controls for each device family. This allows the company to repeatedly reproduce the processes when necessary, and avoid gaps or non-conformities during manufacture or delivery of a medical device. This is why ISO includes the requirement of a medical device file.
Requirements of ISO 13485 Medical Device Files
Medical device files are part of ISO 13485 documents that includes descriptions of design records, manufacturing processes, product specifications, device usage guides, quality measurement criteria, levels of compliance with regulatory bodies and quality standards, and, if required, servicing and installation records and their guidelines. Organizations should develop and maintain a medical device file for each product type or device family. ISO 13485:2016 Certification sets requirements for various elements that should be incorporated in the medical device file. These elements include:
1. Establish and maintain a file for each device family: It is vital to understand a medical device family. The basics of design specifications can be grouped into one family. Therefore, for each group of devices that are considered to be a family, there must be a medical device file.
2. Keep reference documents that show compliance: For each medical device file, the organization should maintain references with their ISO 13485 Certification of conformity and applicable regulatory requirements. This means that the medical device file should either contain the certificate of conformity, or it should refer to any ISO 13485 documents that prove that all processes in the development, manufacturing, packaging, storage, and handling conform to the requirements of ISO 13485. The reference can be a Quality Manual that is based on ISO 13485 and relevant regulatory requirements.
3. Incorporate a description of each family: The medical device file of each product family must include a general description of the medical device, along with its intended use or purpose.
4. Develop and maintain procedures for each medical device family: Each medical device file must contain developed procedures, or specify procedures for production and all associated manufacturing processes.
5. Develop and maintain specifications and procedures for measuring products: The medical device file must contain or consult to documentation of all specifications. It is also necessary to specify the procedure for inspection of devices in this family.
6. Document procedures for servicing and installation: This requirement is exclusive to devices or services that require servicing or installation. The medical device file should maintain, where appropriate, the documented information for installing a device and specifying the procedure for servicing. Documented information for installation of a device may contain steps for installation, or installation records.
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ISO 13485 Certification Requirements 
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