Gokhan Ozalp
Software Engineer with a deep focus on Medical Device Software Quality and Safety.
- Role
- Managing Director at Bioscience Pro
- Location
- Detroit, MI, US
- LinkedIn followers
- 500 followers
About Gokhan Ozalp
For more than 20 years helping medical device manufacturers produce high-quality and safe…
Experience
Managing Director
Oct 2013 — Present · Detroit, MI, US
Managing 510(k) submission processes for Medical Device Startups- Provide full software documentation for software requirements, software design- Perform software risk/hazards analysis- Validation and Verification protocols with full traceability to requirements and design components.Software Life Cycle Process Implementation and Management per ISO 62304- Requirements gathering, requirements identification, and documentation- Software Architectural Design- Software Interface and Detailed Design- OTS evaluation and intended use specification- Validation and Verification planning, test case design, test procedure development- Software Risk Management, risk assignment, risk reporting, and residual risk management- Traceability management, software requirements to design components and test protocol.
Education
Hacettepe University Department of Chemistry
Bachelor of Science in Chemistry
Eastern Michigan University
MSIS, MBA, International Business + Software Engineering
1995 — 2000
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