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
WHO ARE WE? Values & USPs
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.
ENGINEERING DESIGN
QUALITY Technical Excellence INNOVATION Engineering + Design Thinking LEAN Fast Decision Making
MEDICAL ROADMAP
OUR WORKFLOW
DESIGN FOR MEDICAL Design Control & Risk Management
Company Level Actions: ISO 13485 • Formalizing the design process • Quality Management • Document Management •
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,...) •
GOAL “Deliver a device which is safe for use and effective ”
RISK MANAGEMENT “Must be proportionate to the risk associated with the device”
RISK MATRIX
RISK REDUCTION “Risks are reduced as far as possible ”
RISK ↔ BENEFIT Reduction ≠ Elimination
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,...) •
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
medical@comate.be +32 (0) 16 67 02 30
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