Management of medical device files with ISO 13485:2016

24 December 2018

Revision of Medical Devices

Blog by S.M. Waqas Imam, Industrial Engineer, Certified Lead Auditor, Blog Writer and Ambassador of the Medical Devices Community

ISO Technical Committee (TC 210) mandates the requirements of medical device files in the latest version of ISO 13485:2016 in order to make a consistent work flow for manufacturers and suppliers in the medical devices industry. With this change in the standard Quality Management System, it becomes vigilant and it is required to help organisations to meet the regulatory requirements as well, since similar requirements have been stated by regulatory bodies.

Medical device manufacturers and others in supply chain have to manage numerous medical devices. Hence, it is important that these organisations standardise their design and development processes, production processes, medical products record, inspection protocols and enhanced industrial controls for each product family.

Therefore, helping organisations to imitate the processes repeatedly when it is required. This is to prevent any shortcomings or non-conformities during production or distribution of a medical device. Hereby, ISO TC 210 incorporates the need of a medical device file.

Medical device files were not required in the earlier edition of the international standard, i.e. ISO 13485:2003. However, it was a regulatory obligation in many countries, such as Medical Devices Directive 93/42/EEC in Europe, and FDA 21 CFR Section 820 in the United States. With the incorporation of Clause 4.2.3 on the subject of medical device files in ISO 13485:2016, the standard has offered improved value for organisations opting the implementation of standard.

Elements of medical device files

The files are documented guidelines which contain a collection of design records, production processes, medical device specifications, product application guidelines, quality acceptance criteria, compliance status of regulatory, quality standards, and, if needed, servicing and installation records, and their guidelines. Organisations must institute and retain a medical device file for each medical device family or product type. Clause 4.2.3 of ISO 13485:2016 provides requirements for several parts that should be maintained in the file. These elements comprise of following:

  • Create & retain a file for each device family

It is important to recognise a medical device family. For example, Rochester Ochsner forceps, which could be taken as a medical device family. Within this family there are numerous kinds of forceps that can differ in dimensions, clamping, ratchet, handle, serration, material, surface finish, or other design specifications. But, the fundamental of design specifications can be banded together as single medical device family. So, for each set of devices that is reflected to be a family, there must be a medical device file.

  • Maintain reference documents proving conformity

For every medical device file, the organisation must keep references with their Certificate of Conformity to ISO 13485 and relevant regulatory obligations.

This means that the medical device file should either have the certificate of conformity, or it should mention any document that shows that all processes in the design, production, packing, storage, and handling suffice the requirements of ISO 13485, relevant regulatory and legal requirements. The reference can be a Quality System Manual that is established on ISO 13485 and related compliance and regulatory requirements.

  • Include a description of family

The file of all medical device families should include a general description of the medical device, along with its designed application or subject of its use. It should have the approved and documented IFUs, for example; instructions for use. The description contains out of incorporated issues related to labelling, such as device code, name, classification status, bar code and CE requirement.

  • Establish & maintain procedures for the medical device family

Every file must include established procedures, or reference to production procedures and all related manufacturing processes, for instance; packaging, inventory maintenance, safe handling, and shipment protocols of packed finished products. All manufacturing process flows, covering the quality inspection points, for every medical device family must be documented clearly.

  • Establish and keep specifications & procedures for measurement of products

The medical device file should include or state reference to documents containing specifications (such as; product critical dimensions, approved raw material grades, production specifications, and surface finishing specifications) for each unique product type. This means, that all products within a medical device family has their own separated specifications documents. Normally technical drawings contain all this information and each unique product type has its own unique drawing.

These documents should also state the procedure for quality control of devices in a family, the points of inspection in the processes, the critical factors of the products, and type of instruments which will be allocated to check critical points of the product.

  • Establish procedures for servicing & installation

This is a conditional element of the file; it is for devices, that need servicing or installation. Examples are infusion pumps, MRI Scanners, etc. The medical device file should include, where needed, documentation for installation and should state the procedure for servicing. Documentation for installation of a device may have steps, guidelines or installation troubleshooting and can contain records. The procedure for servicing can incorporate the schedule of routine maintenance, qualification of personals doing servicing, checklists for servicing and the flow charts for preventive maintenance and repairs.

The basis for production, distribution and application of medical devices

The idea and elements of medical device files work as the basis for the production processes, distribution and application of medical devices, as they feature all design, manufacturing and application aspects of the medical product lifecycle. Before the prerequisite of the file in ISO 13485, organisations had to observe separate sets of documentation for every aspect of the device lifecycle or they had to consolidate somewhat similar to the medical device file.

The files optimise the production time, avoid processes’ duplication, and curtail shipment damage throughout the manufacturing and shipment processes. It can happen due to vague or confusing production models. Organisations can efficiently manage their production and delivery processes with the help of vibrant, documented procedures that are all centrally consolidated, controlled and integrated in a medical device file for each medical device family.

We want to thank S.M. Waqas Imam for sharing his expertise regarding medical device files with ISO with us. If you have any comments on S.M. Waqas Imam’s story, or if you want to share your own story, please contact us via or +31 630076674.


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