V&V Testing Scope by Sfinitor
Verification and Validation (V&V) testing for medical device software guarantees that it meets functional and non-functional specifications, catering to the needs of intended users. This process encompasses integration and regression testing, requirements-driven system verification, performance evaluation, architectural validation, unit testing, and code scrutiny, among other aspects. Sfinitor offers complete verification & validation testing services ensuring high-quality, secure medical device software compliant with IEC 62304, FDA, and global healthcare standards.
Companies we assist
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- Manufacturers of medical devices
- Medical Software Suppliers for Healthcare Devices
Test rigorous medical device software.
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Encompassing software safety classes per IEC 62340, our services span the entire medical device software lifecycle process spectrum.
- Software Class A: Non-injurious, No Health Risk
- Software Category B: Solutions capable of inflicting limited harm, typically resulting in non-severe injuries
- Class C Software: Potential for substantial harm, including serious injury or fatality
Service Selection: Aid Your Pick
V&V Testing Consultancy Services
Sfinitor's Quality Assurance consultants create a robust testing strategy, selecting appropriate testing types and optimal tools, ensuring the delivery of high-quality software that meets regulatory requirements.
Testing for confirmation and reliability assurance
Functional, performance, security, and compliance testing are executed comprehensively on your medical software, ensuring readiness for clinical validation.
Testing Procedure Explanation
1. Analysis and planning
Medical device software analysis focuses on both functional and non-functional aspects, shaping the subsequent verification and validation testing plan. Testing documentation requirements vary based on the type and safety classification of the software, with more intricate details required for higher risk devices.
Sfinitor's seasoned Quality Assurance (QA) managers collaborate with in-house healthcare consultants to develop verification and validation testing strategies. They select suitable testing tools and form a project team composed of QA engineers, developers for unit testing and static code analysis, security testers, and a compliance consultant. This cohesive unit ensures thorough testing for healthcare software solutions.
2. Testing - Verifying & Validating Quality
Verification and validation testing are performed by our team to uphold the security, compliance with regulations, and intended functionality of your software. The extent of software validation and verification testing is contingent upon the software's safety class.
Identify frequent actions in Verification & Validation (V&V) testing.
- Ensures clear, consistent, and traceable software functional and non-functional specifications for review
- Ensuring clarity, security, and adherence to software architecture and design standards by scrutinizing the layout and construction of software systems
- Code review
- Early error detection through static code analysis prevents post-execution issues
- Code dynamic analysis for detecting potential performance bottlenecks, memory leaks, and program failures during runtime
- Unit testing essential for software safety classes B & C
- Integration testing essential for software categories B and C, ensuring safety
- Testing encompasses functional and non-functional assessments, such as performance, usability, reliability, and security tests, for software categories A, B, and C
- User acceptance testing
3. V&V Testing Outcomes Summary: Pass/Fail
Adhering to IEC 62304 standards, our documentation encompasses comprehensive and consistent details about verification and validation testing processes.
- Comprehensive Software Testing Plan: Defined Acceptance Criteria & Verification/Validation Strategies
- Reports detailing software specifications, architecture, and design validation
- Comprehensive Testing Strategy: API, Integration, and System Levels
- Manual & Automated Testing: Scripts vs Cases
- Comprehensive Test Results Reports include Execution Summaries, Detailed Defect Descriptions featuring Root Cause Analysis, and Software Performance Analyses
Maximize Validation & Verification Testing Efficiency with Sfinitor
Prioritize: Client Business Interests
Gain Advantage: Medical Device Software
V&V Testing via Sfinitor: Enhance Benefits Now
Reducing software testing expenses by 20-40% through key performance indicator (KPI)-driven testing, reusable test documents, and optimized prioritization of testing tasks.
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Why Businesses Choose Sfinitor
Google Partner since 2010.
A quality-first approach based on a mature ISO 9001 quality management system.
Agile approach to achieve efficient results in projects with vague scope.
Recognized for reliability, trustworthiness, and excellence in delivering value.
Expertise in engineering, cloud migration, AWS environment.
Expertise in delivering strategic solutions across the Microsoft Cloud.
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Read moreTrust Sfinitor with Your Medical Device Software Development
- Long-standing career spans software testing; specializing in healthcare IT services
- A great number of accomplished healthcare IT projects showcased in portfolio
- Consultant: MD on deck
- Expertise in healthcare compliance (HIPAA/GDPR), data interoperability (HL7, ICD-10, CPT, XDS/XDS-I), and medical device registration (FDA/CE)
- Ensuring medical software testing adheres to ISO 13485 standards, aligning with FDA and Council of the European Union regulations
- ISO 27001-compliant security management safeguards all customer data in our care
- ISO 9001-certified advanced quality management system
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