Comprehensive Systems and Software Verification of a Wearable Wireless Patient Monitoring Solution for FDA Compliance

About Client

One of the leading medical device OEMs offering a comprehensive range of patient monitoring devices and solutions.

Client’s Challenge

A newly developed wearable wireless patient monitoring system required comprehensive software and system verification to validate functionality and ensure documentation readiness for FDA submission.

iOrbit Solution

iOrbit's Verification & Validation team conducted verification in three stages with focus on product quality and documentation readiness for FDA submission

Continuous testing as part of product development iterations
Formal verification of the software
Formal verification of the system

iOrbit Scope

The verification approach was based on the iOrbit's ISO13485 and IEC62304 compliant processes and FDA guidance for general principles of software validation.

Continuous testing as part of product development iterations aimed at :

Functional testing of development features, anomalies identification and tracking till closure
Retesting for fixed issues and regression testing to identify impact of changes
Formative evaluation of user interfaces and user tasks

Formal software and system verification aimed at addressing :

Coverage of product requirements and software requirements. Requirements traceability to verification protocols, test cases and verification report was created to confirm coverage
Coverage of risk mitigation actions - Safety risk analysis identified design controls and user manual requirements as mitigation actions for some risks, including use related risks. Coverage of these mitigation action was confirmed by creating risk verification protocol and test cases for each of these risk items and traceability of verification report was established in risk management file
Coverage of performance parameters of the system

Deliverables included

Design verification plan and report
Software verification protocols and report with evidences and test logs
System verification protocols and report with evidences and test logs
Software and system anomalies report
Traceability matrix of PRS-SRS-Verification report
Traceability matrix of risks--Verification report

Key Outcome

Continuous testing as part of product development iterations helped in identifying the issues and improving the quality through anomalies resolution.
Formal verification provided documented evidence of meeting the product and software requirements, implementation of risk mitigation actions and performance parameters. These reports helped in making documentation readiness for FDA submission

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