Explained: Medical Device Files of ISO 13485

Medical Device File

The Medical Device Files are documented guidelines. ISO 13485:2016 standard requires MedDev organizations to establish and maintain one or more Medical Device Files. That implies for each medical device type or medical device family, either containing or referencing documents as a proof for conformity to the requirement of this International Standard and compliance with applicable regulatory requirements.

The content of the file(s) is meant to include but is not limited to:

• description of the medical device with the intended use and labeling, including any instructions for use

• specifications for product

• specifications or procedures for manufacturing, packaging, storage, handling, and distribution

• procedures for measuring and monitoring

• requirements for installation (if applicable)

• procedures for servicing (if applicable)

Standardizing a Medical Device

Manufacturers and other organizations have to manage various medical devices since they are included in one or more steps of medical device life-cycle. It is important that organizations standardize their medical products record, design and development processes, production processes, and inspection protocols and enhanced industrial controls for each product family.

When describing a medical device, it is important to recognize a medical device’s family. The fundamental of design specifications can be banded together as a single medical device family. For each set of devices that is reflected to be a family, there must be a Medical Device File.

Medical Device reference

The organizations are obligated to keep references with a certificate of conformity to ISO 13485:2016 for every Medical Device File. The file should have the certificate of conformity or any document that shows that all processes in the design, production, packing, storage, and handling suffice are compliant to the requirements of the standard. Also, relevant regulatory and legal requirements should be mentioned too. The Quality System Manual created according to ISO 13485:2016 can be the reference for the Medical Device File.

The general description of the medical device (families) should be included in the Medical Device File(s). It should be along with its approved and documented intended use.

It is intended for description that contains related issues to labelings, such as device code, classification status, name, bar code, and CE requirement.

Established procedures or reference to production procedures and any related manufacturing processes should be included in that file. For every medical device (family), manufacturing process-flows must be documented clearly.

Medical Device File Content

The Medical Device File should include documents containing specifications for each product type. It is intended for every device within a medical device family to have their own separated specifications documents.

The procedure for quality control, the critical factors of the products, and the type of instruments that will be allocated to check critical points of the product should be included in these documents.

The Medical Device File should include documentation for installation and describe the procedure for servicing if it’s applicable.  

Documentation for installation of a device could have the steps, guidelines or installation troubleshooting and it could contain records.

The procedure for servicing can include the schedule of routine maintenance, qualification of personals responsible for servicing, checklists for servicing and the flow charts for preventive maintenance and repairs.

The Medical Device File can improve the production time and make you avoid process duplication, even reduce shipment damage throughout the manufacturing and shipment processes. The organizations can efficiently manage production and delivery processes with documented procedures that are controlled and integrated into a medical device file for each medical device family.

If you want to know more about the control of documents and reports, you can read it in our next article. Stay tuned.

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2 replies to “Explained: Medical Device Files of ISO 13485”

  1. Rafaella B. says:

    Is the content the same for DHF?

    1. Alexander says:Author

      It’s not the same. In this article, it clearly says that it should include documents containing specifications for each product type. DHF talks about your design controls and how they must be kept in a design history file. It’s simply the collection of documents from the design and development process.

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