MEDICAL DEVICE DEVELOPMENT

Arsenal Products is an Austin, TX based resource for medical device development support. With in-house design, quality system, regulatory, and prototype manufacturing capabilities we are a proven resource to accelerate your device development from concept through manufacturing transfer while reducing your overhead expenses.

Design

  • Concept development and feasibility analysis
  • Detailed device design and analysis
  • Design for manufacturing
  • Design verification and validation

Supplier development

  • Quality Systems
  • Quality system design and assessment
  • Quality assurance auditing and assessment

Regulatory

  • Preparation and management of FDA submissions (510k, DeNovo, PMA) and CE mark
  • Regulatory body meeting preparation and attendance
  • Clinical trial planning and development