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

  • SaMD Software Development & Product Release

 

Compliance & Regulatory

  • ISO 13485 Quality Systems Development

  • QMS Process Creation and SOPs

  • Change Control

  • IEC 62304 Software Problem Resolution Development

  • FDA Cybersecurity Risk Management

  • Cybersecurity SPDF and Threat Modeling

  • AAMI TIR57

  • Audit Preparedness & Mock Inspection

  • Quality Engineering Support - Product Development Teams

  • GMP Training

  • Compliance Gap Analysis

  • 510k Regulatory Submissions - Strategy and Development

  • 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

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