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Expertise

Deep Domain Fluency.

We know your device. From pre-filled syringe to robotic surgery systems, we apply specialized experience to your clinical context.

Medical Devices

  • Total Artificial Hearts (TAH) & MCS (Class III Active Implantables)

  • Surgical Robotics & Navigation Systems

  • Neurostimulators & Implantable Leads

  • Ablation & Interventional Cardiology Systems

  • Lithotripsy & Urology Laser Systems

  • Hemodialysis & Renal Care

  • Infusion Pumps (Volumetric, Syringe & Ambulatory)

  • IV Reconstitution & Bag-Spike Systems

  • MRI, CT, & Ultrasound Imaging

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Combination Products

  • Ophthalmic Micro-Dosing Injectors

  • Vial Reconstitution Kits & Adapters

  • Complex Suspensions in Pre-filled Syringes

  • Mechanical Emergency Auto-Injectors

  • Connected & Electro-mechanical Auto-Injectors

  • Cartridge-Based Insulin Pumps

  • Smart Inhalers (DPI, MDI, SMI)

  • On-Body Delivery Systems (OBDS)

  • Precision Pen Injectors (Fertility & Growth Hormone)

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Digital Health

  • Brain-Computer Interfaces (BCI)

  • Digital Therapeutics (DTx)

  • AI/ML Diagnostic Algorithms

  • Clinical Decision Support (CDS)

  • Hospital Connectivity & EMR Integration

  • Patient Companion Apps & Adherence

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IVD & Diagnostics

  • High-Throughput Central Lab Automation

  • Point-of-Care (POC) Testing

  • LIS Middleware & Data Integration

  • Digital Pathology & Imaging

  • Continuous Glucose Monitoring (CGM)

  • Molecular Diagnostics (PCR/NGS)

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 Fluency in Your Clinical Environment

From brain-computer interfaces to high-throughput diagnostics, we navigate the complex workflows of modern healthcare.

Diabetes & Metabolic Health

  • Cartridge-Based Insulin Pumps

  • CGM Integration

  • Closed-Loop Systems

  • Endocrinology

Cardiology & Circulatory Support

  • Total Artificial Hearts (TAH)

  • Mechanical Circulatory Support

  • Interventional Cardiology

  • Heart Failure

Neurology & Neurotech

  • Brain-Computer Interfaces (BCI)

  • Neurostimulation

  • Spinal Rehab

  • Multiple Sclerosis

  • Pain Management

Urology & Kidney Health

  • Lithotripsy

  • Laser Surgery

  • Dialysis

  • Nephrology

  • Chronic Kidney Disease.

Immunology & Rare Disease

  • Reconstitution Kits

  • Biologics Delivery

  • Rheumatology

  • Haemophilia

  • HIV

  • Orphan Diseases

Pharmacy & Acute Care

  • IV Spike Systems

  • Emergency Auto-Injectors

  • Trauma

  • Wound Care

  • Critical Care Monitoring

Diagnostics & Imaging

  • MRI/CT Workflows

  • Digital Pathology

  • LIS Integration

  • Point-of-Care (POC).

Ophthalmology & Sensory

  • Micro-Dosing Injectors

  • Intravitreal Injections (Retina)

  • Glaucoma

  • Surgical Navigation

Women’s Health & Fertility

  • Precision Fertility Pens

  • Growth Hormone Systems

  • Gynecology

  • Neonatology

Engineered for Compliance.

Our team has deep expertise in ensuring compliance with the relevant standards, guidelines & regulations.

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Global Reach

Audit Ready

Audit-Ready

Core Standards & Guidance

IEC 62366 & ISO 14971

US FDA HF Guidance

AAMI HE75 & HE74

EU MDR (2017/745) & IVDR

IEC 60601 & 62304

AAMI TIR57 & 59

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