Areas we work on
- Drug Delivery Devices
- Dispensing Systems
- Wearable Devices
- Patient Monitoring Systems
- Connected Healthcare Devices
- Storage Devices
- Consumer Healthcare
- Diagnostic Imaging
- Orthopaedics
Our Services Offerings
Research
Brand Strategy
Innovation
Product Development
Electronics Design
Digital Experience
Graphic Design
Packaging Design
Prototyping
Manufacturing Services
Concept to Consumer
Research Innovate
- Co-creation workshops
- Visualization and Mock-ups
- Cognitive walk through
- Functional Analysis
- Formative Usability Studies
- Benchmarking and Competitor Analysis
Design Develop
- Product Conceptualization
- Product Definition
- Requirement Specifications
- System Architecture
- Software and Hardware Design
- Design for Compliance
- Design for Manufacturing
- Design for Product Value
Verify Validate
- Product Compliance Testing
- Pre Compliance Testing
- Finite Element Analysis
- HIL, SIL Script Based Testing
- Functional Testing
- HW-SW Integration Testing
- Performance Testing
Realize Product
- Transition to Manufacturing
- Manufacturing Process Design
- Safety Certifications
- Validation Management Plan
- Quality Management System
Medical Devices - Verification & Validation
Software Quality Assurance
- Code Review
- Configuration Management
- Software Validation
Design Verification
- System Testing
- Automated Testing
- Verification Report
Reliability Testing
- Reliability Test plan
- Reliability Testing by Independent Lab
- Reliability Test Automation
Design Validation
- External Evaluation
- Clinical Trials
Manufacturing Validation
- Device Master Record
- Manufacturing Line validation
- Initial Report
Regulatory Certification
- Filing for CE marking / approval in alliance with UL India
- Approval from Regulatory Bodies
V & V Phase: Modular Engagement Approach
Our Affiliations
V & V Phase: Modular Engagement Approach
- Verification/Testing and Calibration (ISO/IEC 17025:2005
- EMC (IEC 60601-1-2) & Safety (IEC 60601-1/IEC 61010-1)
- Software life cycle processes (ISO/IEC 62304)
- Risk Management (ISO14971)
- EN 12182,EN12184
- UL 1647, FCC Class B, EN 957, CE and applicable product standards
Medical – Quality Consulting & Manufacturing Process Validation
Quality Consulting
- Implementation of Quality Management System (FDA QSR / ISO 13485)
- Risk Management Consulting as per ISO 14971:2007
- Audits and Assessment Services
- Safety certifications through agencies like TUV, UL, CSA
- Gap Analysis with regard to Quality Management System
- Post marketing surveillance activities like CAPA, Post Market Risk Management, Complaint Management, Failure Analysis, etc.
Manufacturing Process Validation
- Requirements Identification for Validation as per ISO 13485
- Validation Management Plan
- Validation Protocols, Tools and Techniques
- Monitoring and Control
- Validation Gap Analysis
- Revalidation & Conformance
To know more about Medical & Healthcare
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