Medical Device Validation.
Inspection-Ready from Day One.
GoVal gives medical device manufacturers a structured, paperless validation platform aligned with FDA 21 CFR Part 820, ISO 13485, IEC 62304, and EU MDR — replacing disconnected documents with a compliant digital quality record.
What is medical device software validation?
Medical device software validation is the documented process of confirming that software used in the design, manufacturing, or quality systems of medical devices performs as intended under regulatory requirements. Required by FDA 21 CFR Part 820, ISO 13485, IEC 62304, and EU MDR, it covers both manufacturing and quality management system (QMS) software, as well as Software as a Medical Device (SaMD). GoVal is a purpose-built Validation Lifecycle Management System (VLMS) that digitises this process — from design controls and risk management to IQ/OQ/PQ execution, traceability, and inspection-ready reporting.
Medical Device Validation is Complex — Paper Makes It Harder
Medical device manufacturers navigate multiple overlapping regulatory frameworks. Paper-based validation adds compliance risk, not assurance.
Multiple Overlapping Frameworks
Satisfying 21 CFR Part 820, ISO 13485, IEC 62304, and EU MDR simultaneously with paper-based systems leads to duplicated effort, version conflicts, and traceability gaps.
Design Control Traceability Gaps
Disconnected Word documents, Excel trackers, and email approvals make it impossible to demonstrate complete design input-to-test evidence traceability during inspections.
Change Control Complexity
Software changes in medical device manufacturing trigger revalidation requirements. Without a structured system, assessing impact and maintaining validated states becomes a significant burden.
Slow Notified Body Submissions
Manual document assembly for Technical Files and Design Dossiers delays EU MDR submissions and prolongs time-to-market for new device programmes.
One Platform for Medical Device Software Validation
GoVal unifies design controls, risk management, IQ/OQ/PQ execution, change control, and reporting into a single compliant platform — built for the multi-framework demands of medical device manufacturing.
Design Controls & Traceability
Capture design inputs, link to design outputs, and trace through V&V test evidence — maintaining complete 21 CFR Part 820 design control traceability automatically.
IEC 62304 Software Lifecycle
Manage software development lifecycle documentation, software class classification, unit and integration testing evidence, and maintenance records aligned with IEC 62304.
Paperless IQ/OQ/PQ Execution
Execute qualification protocols for manufacturing software and QMS systems digitally — with real-time recording, deviation management, and automated RTM linking.
Change Control & Impact Assessment
Structured change request workflows with GxP impact assessment, re-validation scoping, approval routing, and post-change verification — maintaining validated state continuously.
21 CFR Part 11 E-Signatures
Compliant electronic signatures with meaning statements, role-based identity verification, and timestamped approval records — valid for FDA and EU notified body submissions.
Inspection-Ready Dashboards
Real-time project status, validation state overview, and one-click inspection packages — ready for FDA 483 responses, ISO 13485 audits, and EU MDR Technical File compilation.
Every Medical Device Validation Framework, One Platform
GoVal is designed to satisfy the overlapping regulatory requirements of FDA, ISO, and EU medical device compliance — simultaneously.
FDA Quality System Regulation
Design controls, CAPA, complaint handling, and production/process controls with full electronic records compliance.
Medical Device QMS
Validation of software used in manufacturing and QMS processes — clause 7.5.6 and 4.1.6 compliant documentation and records.
Software Lifecycle
Software development, maintenance, and risk management documentation for SaMD and embedded device software.
EU Medical Device Regulation
Technical File documentation, post-market surveillance software requirements, and notified body audit readiness.
Faster Submissions. Cleaner Audits. Continuous Compliance.
One platform supports FDA, ISO, and EU requirements — eliminating duplicate documentation across regulatory regimes.
Structured validation records and one-click report generation compress notified body submission timelines significantly.
Close the traceability and e-signature gaps that most commonly trigger FDA 483 observations in medical device inspections.
Structured impact assessment and re-validation workflows keep your systems in a continuously validated state through every software update.
Medical Device Validation Questions Answered
What is medical device software validation?
Medical device software validation confirms that software used in device design, manufacturing, or quality systems performs as intended and meets regulatory requirements. Required by FDA 21 CFR Part 820, ISO 13485, IEC 62304, and EU MDR, it covers both QMS software and Software as a Medical Device (SaMD).
What regulations govern medical device software validation?
Key frameworks include FDA 21 CFR Part 820 (Quality System Regulation), ISO 13485:2016 (Medical Device QMS), IEC 62304 (software lifecycle), EU MDR 2017/745, and ISPE GAMP 5. GoVal is built to satisfy all these frameworks simultaneously in a single compliant platform.
Does GoVal support FDA 21 CFR Part 820 design controls?
Yes. GoVal aligns with 21 CFR Part 820 design control requirements — covering design inputs, design outputs, verification and validation testing, design review documentation, and traceability matrices. All records include 21 CFR Part 11 compliant e-signatures and immutable audit trail.
How does GoVal support ISO 13485 compliance?
GoVal supports ISO 13485 clause 7.5.6 and 4.1.6 requirements for software used in manufacturing and QMS processes — providing compliant validation records, e-signatures, change control, and audit trail for both FDA and EU notified body inspections.
What is SaMD validation and how does GoVal support it?
SaMD (Software as a Medical Device) validation follows IEC 62304 and FDA's Software Guidance. GoVal supports the full SaMD development lifecycle — risk management per ISO 14971, verification and validation records, and complete requirements-to-test traceability.
How does GoVal improve inspection readiness for medical device manufacturers?
GoVal maintains all validation documentation, audit trails, and approval records electronically with real-time dashboards. Inspection packages are assembled in under one hour — replacing days of manual retrieval from paper binders for FDA 483 responses, ISO audits, or EU MDR Technical File submissions.