WHO ARE WE? Values & USPs MEDICAL ROADMAP Development process - - PowerPoint PPT Presentation

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WHO ARE WE? Values & USPs MEDICAL ROADMAP Development process - - PowerPoint PPT Presentation

Oct 12, 2023 7 likes •292 views

WHO ARE WE? Values & USPs MEDICAL ROADMAP Development process of a medical Device OUR WORKFLOW Comates process for product development DESIGN FOR MEDICAL Design Control & Risk Management WHO ARE WE? Values & USPs GIVING IDEAS

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WHO ARE WE?

Values & USPs

MEDICAL ROADMAP

Development process of a medical Device

OUR WORKFLOW

Comate’s process for product development

DESIGN FOR MEDICAL

Design Control & Risk Management

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WHO ARE WE?

Values & USPs

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GIVING IDEAS THE BEST CHANCE TO SUCCEED

Our goal is to develop unique products that are more innovative and more advanced than anything currently available, and to find solid and tailored solutions in a short time frame to help our clients realize their dream.

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ENGINEERING DESIGN

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QUALITY

Technical Excellence

INNOVATION

Engineering + Design Thinking

LEAN

Fast Decision Making

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MEDICAL ROADMAP

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OUR WORKFLOW

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DESIGN FOR MEDICAL

Design Control & Risk Management

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Company Level Actions:

  • ISO 13485
  • Formalizing the design process
  • Quality Management
  • Document Management
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Company Level Actions:

  • ISO 13485
  • Formalizing the design process
  • Quality Management
  • Document Management

Device Level Actions:

  • ISO 14971
  • Device specific norms (IEC)
  • Safety & performance requirements MDR (EU) 2017/745
  • Reducing potential risk (FMEA, PHA,...)
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GOAL

“Deliver a device which is safe for use and effective”

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RISK MANAGEMENT

“Must be proportionate to the risk associated with the device”

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RISK MATRIX

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RISK REDUCTION

“Risks are reduced as far as possible”

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RISK ↔ BENEFIT

Reduction ≠ Elimination

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Company Level Actions:

  • ISO 13485
  • Formalizing the design process
  • Quality Management
  • Document Management

Device Level Actions:

  • ISO 14971
  • Device specific norms (IEC)
  • Safety & performance requirements MDR (EU) 2017/745
  • Reducing potential risk (FMEA, PHA,...)
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LOOKING FOR A PARTNER IN DEVELOPMENT?

Don’t hesitate to reach out to see how we can support your

  • project. Give your idea the best chance to succeed.

Medical@comate.be +32 (0) 16 67 02 30 https://www.comate.be

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medical@comate.be +32 (0) 16 67 02 30