Bioscience Pro is a Software Engineering company designed to help Medical Device Manufacturers and startups with their Software Quality Assurance for regulatory compliance and FDA submissions. Bioscience Pro is owned and operated by software engineers with expertise in Medical Device software development, software quality, software V&V, software documentation per ISO 13485, IEC 62304, and IEEE standards. Bioscience Pro provides the following capabilities:
- Software Quality Management per IEC 62304. 
- Software Risk Analysis per ISO 14971.
- Software Documentation and Remediation
- Software V&V Strategy and Planning
- Cybersecurity Risk Management Process development, Cybersecurity Risk Management Planning, and Documentation
- OTS Validation
- Validation of Automated Process Equipment and QS Software
- AI/ML Process development per FDA's Action Plan
PRESS RELEASE 2022! Bioscience Pro is pleased to announce the 2022 release of our much anticipated proprietary early-stage medical device vetting investor service, SmartMed PRO®. Only SmartMed PRO® thoroughly investigates (QMS) Quality Management System compliance with 21 CFR 820 and ISO 13485:2016 to determine if the startup model has designed and implemented vital processes at the infancy of development. Our unique in-depth 50-point analysis provides a clear and concise evaluation to determine the viability of the medical device startup. SmartMed PRO® is a service offered exclusively through Bioscience Pro Software Engineers, a company with 20 years of medical device regulatory experience.
“I developed SmartMed PRO® as a response to 20 years of real-life medical device software engineering experience. Venture Capital organizations want to acquire disruptive technology for early-stage startups. Seed money investors risk millions based on this valued asset technology. Unfortunately, a long and drawn out FDA clearance path diminishes returns, increases costs, and leaves the door open for competitors.”
Gokhan Ozalp, CEO

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