Medical
Devices

Medical Device Software Development

Design and development of software for medical devices ensuring safety, reliability, and compliance to standards such as ISO 13485 and IEC 62304:

• User interfaces
• Control algorithms
• Data storage, and communication protocols

Consulting Services for ISO 13485 & IEC 62304 Compliance

Consulting services covering:

• Assessment to identify gaps
• Followed by remediation steps to ensure
• Your Medical Device software development life cycle process is fully compliant with ISO 13485 and IEC 62304.

Verification of Medical Devices

• Functional and performance testing.
• Design & System Verification.
• Verification against FDA's Quality System Regulation (QSR) for the development processes.
• Verification for compliance to FDA's cyber security guidance.

Validation of Medical Devices

• Automated testing, continuous testing, including regression testing
• Validation of Code and tools.
• Validation to ensure they meet FDA 21 CFR Part 820 requirements.
• Design validation and real-time testing to validate response time, performance under load, and system reliability.
• Validation of cyber security guidelines with penetration testing, threat modeling, and vulnerability assessments, etc.

Traceability & Documentation for Regulatory Approval

• Full traceability of all requirements - from design to code to testing are documented and verifiable.
• Support for submission processes to FDA, CE marking, and other certification authorities.

Design and Development of Companion Apps

• Design and development of mobile, web, and cloud applications that enhance the functionality of primary medical devices and associated services.
• Ensure that the apps are working seamlessly integrated with hardware devices, software platforms, and back-end web services.
• UI and UX design.
• Addition of advanced features- data visualization, analytics, system configuration & customization, notifications, user authentication, and social sharing etc.
• App store submission, deployment, and ongoing maintenance.

Industry & FDA Approvals

• Consulting services to help achieve and maintain compliance with ISO 13485 and IEC 62304.
• Software validation as per FDA's guidance including design control, verification, and validation activities.
• Risk management and validation aligned with ISO 14971 standards.
• Development of automated test suites to streamline the validation process for compliance with industry regulations.
• Traceability & Documentation for Regulatory Approval
• Cybersecurity Testing for FDA & Industry Standards.
• Support for submission processes to FDA, CE marking, and other certification authorities.

Production Management Services

• Ensure a smooth transition from design to production and beyond.
• DFM (Design for Manufacturing) and DFA (Design for Assembly) support to optimize product designs for efficient, cost-effective production.
• Supply Chain & Procurement Management with inventory management, forecasting, and logistics coordination to maintain a steady flow of materials for production.
• Logistics & Fulfilment with management of shipping, warehousing, and distribution channels to ensure timely delivery of products to global markets.
• Ensuring production processes and products comply with relevant international standards and regulations (such as CE, FCC, UL, ISO, and RoHS).
• Implementation of rigorous quality measures, including test tools, test jigs, and evaluation kits.
• Support for submission processes to FDA, CE marking, and other certification authorities.