Qualification of IT systems used to ensure quality and medical-device design is essential. This follows Article 4.1.6 in ISO 13485:2016 as well as European and FDA directives.

To help customers save time when building and maintaining their validation files linked to the software program, we provide the turnkey version of Medical Device Suite’s RM 14971 module with a corresponding validation file.

ISO 14971 Software Validation File Content

This file contains all of the documents required to demonstrate the quality of the medical device software programs and tools (programs used during the life cycle).

This file uses the risks analyses carried out by Knowllence to identify potentially critical elements needing specific tests.

The validation file in ISO 14971 tool comprises: 

• A Validation Master Plan (VMP) that defines the chosen validation policy

• Validation Protocols (VP) in two specific documents covering the following validation phases:

• Installation Qualification (IQ) 

• Performance Qualification (PQ)

• A Validation Summary Report (VSR) covering the following validation phase: 

• Operational Qualification (OQ) 

• A collection of additional documents 

Choices for Customers: 

• Rebuild the entire file themselves 

• Rely on the validation file provided by Knowllence 

• Ask Knowllence to provide full support for the qualification of the software 

Installation, Performance, and Operational Qualification

The Installation (IQ) and Performance (PQ) qualifications must be carried out at customers’ sites. Knowllence proposes a turnkey version of the software and the protocols to execute once the software is installed. Customers must build the evidence files connected to the qualification report for the IQ and PQ sections.

For the Operational Qualification (OQ), the validation report comes with the protocol for the tests, results, and related evidence.

Knowllence can provide an additional service for customers who would like to carry out complete Installation and Performance Qualifications in the final environment.

Customers can also run the protocols themselves, with Knowllence providing periodic support if needed.As expected, Knowllence updates the validation files at the same time as the Medical Device Suite RM 14971 tool.

BASSETTI China and Knowllence

BASSETTI group is continuously acquiring companies with related activities in synergy with its core business to allow them to broaden their skills and respond more strongly to the needs of its customers.

The acquisition of KNOWLLENCE allowed the company to develop its expertise in risk management. Besides providing a FMEA software solution adapted to latest AIAG-VDA Standard, Knowllence also provides a software solution for Medical Devices – Medical Device Suite Software.

For more information