Our Mission

Advance medical device and combination product risk management by providing cutting-edge software solution and expert consulting.

Our Vision

Make effectiveness and productivity in assuring safety, cybersecurity and regulatory compliance a competitive advantage for our clients

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- Streamlined, automated, and connected dots ... 

- Predictive regulatory submissions, inspections, compliance issue closure

- Accelerated regulatory review for new product clearance

- Reduced cost, and time to market

- Risk-driven quality management systems

- Peace of mind on product safety and regulatory compliance

- Staying ahead of the curve with the best industry practices

Our Values

Client Success and Satisfaction

 

Safety, Cybersecurity, Compliance, Productivity, Time to Market, and Innovation

 

Integrity, Creativity, Teamwork, Openness, Self-Discipline, Diversity, Gratitude, Compassion, and 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 quality, reliability and risk management for medical devices. Our software solutions are rooted in engineering science and best practices.

We know 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.

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