Design Controls for New Devices


At BDL Consulting we back up our Medical Device Product Designs with the Design Control documents required to support the regulatory requirements for New Products release. All Design Controls conform to European CE Marking and USA FDA directives. Bartek work closely with your Quality Assurance Teams to develop the Design Control Inputs, User Needs, requirements and specifications to populate your DHF to have it ready for the CE Marking or 510K submissions to achieve as successfully market product release. Contact us for details.

Design Control Documents for the DHF

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1. User Needs

  • Process Scope / URS
2. Design Input

  • Product Specifications
3. Design Process

  • Engineering Design
  • CAD Models, Drawings
  • Material Specifications]
  • Manufacturing Processes
  • Design Assurance Documents

4. Design Output

  • Prototyping
  • Testing / Clinical Trials
  • Verification
  • Design Freeze
  • Manufactruing Equipment
5. Medical Device

  • Validations
  • Production
  • Market Release
  • Customer Care