Topic: Risk Management for Medical Device Development & Testing
Speaker: Venudhar Hajari
Bio:
Venudhar Hajari is a seasoned Quality and Systems Engineering professional with over 20 years of experience spanning medical device development, verification, and risk management. Currently serving as a Staff Quality Assurance Engineer at Smith & Nephew, he leads cross-functional teams in system requirements creation, design verification, and regulatory compliance for advanced surgical devices targeting ENT, orthopedics, and sports medicine.
His expertise includes developing and validating high-frequency surgical equipment in compliance with IEC 60601, ISO 13485, FDA 21 CFR Part 820, and MDR standards. Venudhar has a strong background in risk management, driving the creation of robust Failure Mode and Effects Analysis (FMEA), process validations, and risk control documentation essential for FDA 510(k) and CE Mark submissions.
Throughout his career, he has contributed to system and software verification of PET/CT scanners and digital imaging platforms, implementing automated test frameworks and leading V&V strategy planning.
With a combination of hands-on testing skills, systems integration expertise, and in-depth knowledge of global regulatory expectations, Venudhar is committed to delivering safe, effective, and high-quality medical devices that meet rigorous industry standards.
Agenda:
630-720pm: Meet and Greet/Buffet*
730-830pm: Speaker presentation/Q&A
*Light buffet-style food catered from HEB and refreshments will be provided, as well as raffle prizes. Feel free to access the full bar at the hotel; ASQ will only be providing non-alcoholic drinks.
Presentation Agenda:
Welcome and Objective (5 min)
- Why risk management is critical
- Overview of regulatory expectations
Foundations of Risk Management (10 min)
- Definitions (Hazard, Harm, Risk)
- Basic concepts from ISO 14971
- FDA QSR overview
ISO 14971:2019 Process Overview (10 min)
- Planning
- Risk Analysis
- Evaluation
- Control
- Residual Risk Evaluation
- Post-production feedback
Practical Application (10 min)
- Tools (FMEA, FTA)
- Integration into design controls
- V&V strategies
- Traceability examples
FDA Expectations (5 min)
- Benefit-risk focus
- Guidance documents
- Documentation
Q&A and Wrap-up (5 min)
Location:
SpringHill Suites Austin Cedar Park
1110 Discovery Boulevard Cedar Park, TX 78613
Cost / RUs
0.1 RU per hour will be awarded after physical check-in. To reserve a seat, make sure to register with the attached link, CLICK HERE.