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Control of infrastructure

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Guest user Created:   Apr 29, 2020 Last commented:   May 04, 2020

Control of infrastructure

I read your article on Managing Medical Device Infrastructure and we are wondering to what level of detail and validation we have to go. For example, we have measuring equipment that requires calibration, so we create validation records for each piece of equipment, including calibration schedules and service schedules. We also have a large volume of software, for example document writing, spreadsheets, ERP systems, Finance system, etc etc etc. We also have computers for development that our development team uses, computers for service delivery that our programmes run on. The same question applies, we wonder if we need records for each computer, each desk, each software package. Can you provide any clarity in this area for us at all?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić May 04, 2020

Considering software validation, in requirement 4.1.6 of ISO 13485:2016 that activities associated with software validation must be proportional to the risk associated with the use of the software. Therefore, it is up to you to define which software can influence both quality of the medical device and the management system.  

Considering the maintenance of the infrastructure, in requirement 6.3 Infrastructure of ISO 13485:2016 is stated that organization must document requirements and records for the maintenance activity when such maintenance or lack of it, can influence the product quality. These requirements must definitively apply to equipment used in production (e.g. different machines used in the production of medical device: molding machine, packaging machine), control of the work environment (e.g. equipment for measuring temperature and humidity), and monitoring and measurement (e.g. scales, thermometers, pressure valves).

Therefore, no, you do not need records for each computer and each desk, rather for those that can on any way influence on the quality of your device and/or service (e.g. following software definitely need validation: software used in the calibration of equipment, software that manage production, software that manage quantities in storage and manages invoices and delivery notes). 

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Apr 29, 2020

May 04, 2020

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