Ximedica Loop MDG Matchmaking

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Slide 1: 

Every project begins at the end. the end user. the end goal. the end product. the end result. PILOT MANUFACTURING CLINICAL & REGULATORY STRATEGY RESEARCH ENGINEERING HFID

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We help our clients innovate customer-driven and commercially viable new products and get them to market successfully.

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Integration from research to implementation speed to market • risk reduction • accountability

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People, Process, Perspective 20+ year track record • ISO 13485:2003 certified • FDA registered 80,000 sq. ft. flagship facility with multiple clean rooms • Hong Kong operations

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Client Experience People, Process, Perspective

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Clinical Devices Endoscopy Laparoscopy NOTES Emergency care Blood salvage & reinfusion Diagnostic imaging Respiratory therapy Drug delivery systems Urologic ablation Nerve stimulation Consumer Healthcare Drug dosing & delivery Medication compliance Home diagnostics & remote monitoring First aid & pain management Cosmeceuticals Diabetic care Personal care Healthcare Systems ER/Resuscitation Bays Retail & Mail Order Pharmacy PBM Systems Hospital SafetySurgical Error Prevention Areas of Expertise

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Insights that inspire. Concepts that connect. Strategies that deliver. Expert qualitative and quantitative methods • Clinical and non-clinical settings • Voice of the Customer (VOC) studies • Ethnography • Concept testing and validation Human factors studies • Commercial assessment and product strategy • Medical simulations Clinical trial design and execution • Wide access to healthcare providers and experts Research, Strategy & Concept Generation

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Every product is the opportunity to create a beautiful user experience Human factors and ergonomic design Industrial design • Usability • Design engineering • Rapid prototyping Anthropometrics • User testing • Interface design Human Factors Industrial Design

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Technical development for products that are built to succeed. Mechanical and electrical engineering • software engineering and system architecture Design for manufacture and assembly • Quality engineering • Design verification FMEA • Finite element analysis • Mold flow analysis Engineering

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Comprehensive regulatory compliance services Global regulatory strategy • Pre-IDE/IND FDA meetings and applications 510(k), PMA and NDA submissions • Import/export certification • Clinical trial design • Study execution Document control and data management • Study report and clinical regulatory submission Clinical & Regulatory

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Integrated manufacturing assembly from pilot to full scale production Production planning • Process validation, IQ/OQ/PQ • Parts inspection and qualification Clean room assembly and testing • Secondary operations, kitting and packaging Sterilization • Global Sourcing • Sustaining engineering and cost reduction Advanced Manufacturing

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Every project begins at the end.

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