ABOUT US
Our Mission
Advance medical product safety engineering by providing the best practice-based software tools and expert consulting.
Our Vision
Best in class one-stop solutions for the development and maintenance of safe, effective, and compliant medical products.
Reduced time to market
Reduced total cost of product
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Streamlined product development
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High confidence in regulatory submission & approval timeline
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Ahead of the curve with the industry best practices
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Total life cycle of safe and effective products
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Peace of mind on regulatory compliance
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Risk-driven quality management systems
Our Values
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Client Success
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Safety
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Effectiveness
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Cybersecurity
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Reliability
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Compliance
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Time to Market
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Simplicity
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Innovation
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Integrity
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Creativity
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Teamwork
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Openness
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Self-Discipline
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Diversity
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Compassion
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Gratitude
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Sharing
Who We Are
We are practitioners and experts in medical device safety, cybersecurity, quality and regulatory compliance management. We had years of experiences working in the medical device industry before founding GessNet.
We understand our clients' day to day challenges. We have lived through it, and understand that a practical, effective, and agile software tool can make a huge difference.
We understand regulatory compliance needs. We stay active in engagement and communications with standard development organizations and regulatory agencies/notify bodies.
We have years of hands-on experience in design controls, risk management, cybersecurity, reliability, and safety assurance cases for medical devices. Our software solutions are rooted in engineering science and best practices.
We can help you to define and implement what is the most suitable practice for you. We have seen and experienced with many of industry practices.
We understand software. We know what software can do to streamline and automate your work and help you. More than being simple tools, our software solutions have built in expertise and intelligence for establishing the industry best practices.