Verification and Validation
The only way to ensure a successful product and regulatory approval of your next medical device, is to include strategic Verification and Validation services as part of your deployment. Optra’s Verification and Validation services guarantee an enhanced user experience, increased productivity and reduced time-to-market to keep your business processes competitive and compliant
Our wide spectrum of Product V&V services in the Medical Devices and Lab Automation space covers the product lifecycle from the requirements definition phase, System Verification & Validation, all the way to product deployment and documentation for regulatory approval and certification. With deep domain knowledge and hands-on experience, we address the testing issues by employing an end-to-end testing lifecycle offering.
1. Medical Devices
- Diagnostics devices
- Monitoring devices
- Therapeutic devices
- Clinical imaging devices
- Medical pumps
- DNA analyzers, immunoassay analyzers
- Information systems (connectivity to devices) in lab automation
2. Lab automation
- Device interfaces and integration
- Workflow engine and data informatics
- Monitoring and controlling operations
Our specialized services encompass the complete testing lifecycle:
- Computer System Validation, 21 CFR Part 11
- Independent product Verification and Validation
- End-to-end product Verification and Validation
- Validation in all phases for various coverage analysis using standard tools or test frameworks
- Best practices to ensure quality of deliverables through static analysis, document reviews, quality probe, etc.
- V&V framework design, development and execution per customer needs
- Test strategy, planning, design, development and execution on COTS automation tools
- In-house Test Automation Framework (OTAF) customization per customer needs
- Hardware testing coverage—functional, parametric, interfaces, electro-mechanical configurations
- Localization or internationalization testing
- Product testing metrics monitoring and control as per in-house quality processes or aligned to customer quality management system (QMS)
- Product specifications traceability up to various test specifications across the life cycle
- Consultancy on test strategy, manual/automation testing, testing coverage, tool selection, etc.
- Regulatory compliance testing services aligned to ISO 13485, etc.
- Experience with US and European regulatory agencies – FDA, CE, etc.