Why Medical Devices & Instrumentation Need Next-Gen Solutions

Regulatory Pressure

Devices must comply with FDA, ISO, and global standards for safety and performance.

System Complexity

Integration of hardware, firmware, and software for diagnostics and lab instruments is highly specialized.

Patient Safety & Reliability

Products must undergo rigorous testing and validation to ensure consistent, accurate results.

Innovation Speed

Time-to-market is critical for competitive advantage.

Specialized Expertise Gaps

Companies need access to domain-specific engineers, QA, and validation experts.

Solutions We Deliver

Device Engineering

Hardware, firmware, embedded systems, and mechanical engineering for medical and diagnostic devices.

Testing & Validation

Manual and automated testing, creation of test plans, defect tracking, and compliance documentation.

Instrumentation Engineering

Software, firmware, and data acquisition systems for diagnostics, spectroscopy, and analytical instrumentation.

Compliance & Regulatory Support

Verification and validation aligned with FDA, ISO 13485, HIPAA, and global healthcare standards.

Lifecycle Support

From early prototyping and board bring-up to manufacturing support, upgrades, and product sustenance.

Specialized Staffing Services

Onshore and offshore staffing for QA engineers, validation specialists, instrumentation experts, and device engineers.

Why Envisage?

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End-to-End Expertise

Hardware, software, validation, and compliance under one partner.

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Regulatory Strength

Deep experience with FDA submissions and global compliance frameworks.

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Global Delivery Models

Onshore, offshore, and hybrid engagement to fit project needs.

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Flexible Engagement Models

Onsite staffing, mixed-shore engineering, or turnkey projects.

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Trusted Partnerships

Long-standing collaborations with global medtech and instrumentation leaders.

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Faster Time-to-Market

Agile engagement models and automation-led testing accelerate delivery.

Case Studies