Our Expertise Across Domain

 

New Product Development

  • Design Feasibility

  • Customer Needs -> Product Requirements

  • ISO 14971 Risk Management

  • Cloud Hosting Applications

  • IEC 62304 & TIR45, AGILE Software Development

  • Software Lifecycle Management

  • IEC 62366 Human Factors & Usability Engineering

  • Design Verification; Test Case Development & Protocol Writing

  • Defect Management & Software Problem Resolution

  • Design Transfer

  • Software & Product Release

 

Compliance & Regulatory

  • Quality Systems SOP Development

  • QMS Process Creation

  • Change Control

  • Audit Preparedness & Mock Inspection

  • Quality Support - Product Development Teams

  • GMP Training

  • Compliance Gap Analysis

  • 510k Regulatory Submission

  • IVDR Performance Evaluation Preparation

Testing & Production

  • Validation Test Plan & Protocol Creation

  • Computerized System Validation (CSV)

  • Software Tool Qualification & Governing SOP development

  • Process Validation

  • Test Method Validation

  • Kaizen Process Map Evaluation

Contact us.

Let us help you turn ideas into healthcare solutions.