I am manufacturer of medical devices. Must I validate the software that I use in my production, preparation service and control activities?
ISO 13485: 2016 specifies that the organisation must establish documented procedures for the validation of the software application (and changes of such software and / or its application) for production and service preparation that affect the ability of product to meet specified requirements.
These software applications must be qualified and validated before first use.
Using Nex’valid means:
- Identification of software and applications that fall within the scope of the standard;
- Definition, review and approval of your validation process;
- Validation of the application of the software including the development or updating:
- Your director validation plan, process software validation plan, risk analysis associated with the software, installation (IQ), operational (OQ), and performance (QP) qualification, and the final validation report;
- Your procedures for process software (life cycle, development of validation documents, coding, etc.).
Result of Nex’valid for your business:
- Significant reduction in the risk of stopping an activity (related to dysfunction) and loss or corruption of data;
- Assurance of compliance with applicable regulatory requirements;
- Guarantee that your system meets the needs of users within your company.
What happens in case of non-compliance?
In case of non-compliance with regulatory requirements, you risk a sanction from the notified body up to a suspension of marketing your products and / or withdrawal from the market if it is justified.