Product Design & Prototyping

  • 3D Design & Modelling
  • PCB Design
  • Additive Manufacturing
  • Subtractive Manufacturing
  • PCB Manufacturing

Regulatory Compliance

  • Technical File Preparation for FDA/CE
  • Clinical Evaluation Report (CER)
  • Biological Evaluation Report (BER)
  • Implementation of Quality Management System
  • ISO 13485: Compliance & Certification
  • ISO 14971: Risk Management & Analysis
  • Software as a Medical Device (SaMD)

Software & AI Solutions

  • AI & Machine Learning
  • DevOps / Cloud Computing
  • Application Development
  • UI/UX Development
  • Software Quality Assurance (SQA)
  • Software Development Lifecycle (SDLC)
  • Software Testing Lifecycle (STLC)
  • Software as a Medical Device (SaMD)

Quality Testing

  • Quality Plan
  • Bench Testing
  • Physico-Chemical Testing
  • Visual Inspection
  • Dimensional Analysis
  • Defect Analysis
  • Packaging Integrity Testing
  • Simulation

Electronics & Firmware Development

  • Firmware Deisgn & Development
  • Electronics Design & Development
  • Design Verification & Validation

Turnkey Commissioning of Product Lines & Regulatory Approvals

  • Supply & Commission of RMT Production Machines
  • Installation & Training
  • Commissioning and Validation Support
  • HR Training
  • Operation and Performance Qualification (OQ/PQ)
  • ISO 13485 Implementation & Certification
  • Product Licensing & Regulatory Approval

Pharmaceutical Product Development

  • Pharmaceutical Formulation & Coating
  • Drug Development & Delivery Systems
  • Recipe Verification & Optimization

Contract Manufacturing

  • Active Medical Devices
  • Non-Active Medical Devices
  • Injectables
  • Wearables
  • Drug Delivery Vehicles
  • Intravascular Devices
  • Implantable Devices
  • Consumables/Components
  • Biosensors
  • Specialized Biomaterials