Medical Device 2013 - Risk Management ISO 14971 for Medical Devices

Topic”
Risk Management ISO 14971 for Medical Devices
Level of the Training:
Intermediate to Advance
Why Should You Attend:
- R&D Engineers / Managers
- Quality Assurance Personnel
- Regulatory Affairs Personnel
- Advanced Manufacturing Personnel
- Manufacturing /Operations Personnel
- Consultants
- Quality System Auditors
Description of the Topic:
Medical Device Companies are using different tools to identify and manage the risks but some companies lack the over all process to connect the dots. This gap has resulted in several field failures and significant recalls of the products due to inappropriate prioritization of risks involved. ISO 14971 provides a comprehensive model to not only identify the risk, but also to prioritize and mitigate the risks to as low as reasonably possible. The scope includes the entire product realization process including the after life disposal of the devices. This presentation will discuss the key elements of the process and how to connect different activities to better understand the product and process risk and risk mitigation.
Areas Covered in the Session:
- Risk Management Plan
- Risk Analysis (Intended Use, Identification of Hazards, Estimation of Risks
- Risk Evaluation
- Risk Control (Risk Control Option Analysis, Implementation of Risk Control Measure(s), Risk/benefits analysis
- Evaluation of overall residual risk acceptability
- Risk Management Report
- Production & post-production information.
Who Will Benefit:
Mid to Large Medical Device Companies (both OEMs and Suppliers)
Speaker profile
Over fifteen years of Product Development, Quality Engineering & Management experience for Medical Devices (PMA & 510K Implants & Instruments) and Automotive Components. People/function management experience including performance management, development plan, resource plan, budgeting and control. Experienced in Product Development, Design Control, and compliance to CFR 820.30 including VOC, User Needs, Design Inputs, Design Verification & Validation and Design Transfer. MBA, MS (Manufacturing Engineering), BS (Mechanical Engineering). ASQ Certified Six Sigma Black Belt (CSSBB), Certified Quality Engineer (CQE) & Certified Reliability Engineer (CRE). Experienced in Risk Management (ISO 14971), Project Management, FDA Audits & Process Validation (IQ/OQ/PQ), Supplier Qualification, CAPAs. Worked as assistant coach for Dale Carnegie Training Institute for Communications Skills Experienced in working with multi-national teams including from Europe & Asia.
Specialties:Product Development, Design Control, Risk Management, Reliability Engineering, Six Sigma, Statistics, Process Validation.
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