Medical Device Quality and Design
Issued by
UCSC Silicon Valley Extension
Recipients learned about cutting-edge advancements in digital health, wearable devices, and medical software. They delved into regulatory compliance and global quality standards, covering FDA requirements, EU regulations, and ISO guidelines. They've gained practical skills in risk management, documentation development, and human factors usability planning, ensuring designs meet user needs and mitigate risks.
- Type Learning
- Level Advanced
- Time Months
- Cost Paid
Skills
- Biologics
- Clinical Sciences
- Data Analytics To Support Decisions
- Design
- Emerging Technologies
- Engineering
- Ethics
- FDA
- Human Factors
- In Vitro Diagnostic Devices
- IS 13485
- Life Sciences
- Marketing Medical Devices
- Medical Device Development
- Medical Devices
- Medical Software
- Natural Sciences
- Negotiation
- Planning
- Process Validation
- Product Development
- Product Life Cycle
- Program Management
- Regulatory Affairs
- Regulatory Compliance
- Regulatory Requirements
- Research
- Research Design
- Risk Management
- Technology
- Usability
Earning Criteria
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Completed a selection of core courses to meet required units. Earned 14 units. Met all requirements for a UCSC Silicon Valley Certificate in Medical Devices.
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Several UCSC Silicon Valley Extension's Medical Device Quality and Design certificate courses meet the criteria for pre-approved recertification credit(s) for Regulatory Affairs Certification (RAC). As a Regulatory Affairs Professional Society (RAPS) RAC Recertification Approved Provider, each course is valid for a designated number of PDCs for the RAC recertification requirements.