Innovating Healthcare Solutions

Welcome to GK Medtech

Expert Consulting Team

Innovative Solutions

Our team at GK Medtech comprises seasoned professionals with diverse backgrounds in university research, industry leadership at top medical device firms, and successful ventures in the startup ecosystem. With a dedicated medical device regulatory specialist on board, who actively contributes to shaping industry standards, we are well-equipped to guide you through compliance requirements and deliver cutting-edge solutions tailored to your needs.

Our Mission

GK Medtech

Our mission is to empower medical device companies with expert guidance in biomaterial development, biocompatibility testing, and regulatory compliance. Leveraging our extensive academic research, industry experience, and regulatory expertise, we aim to accelerate innovation while ensuring the highest standards of safety and effectiveness. We are committed to helping our clients bring cutting-edge medical devices to market efficiently and in full compliance with international standards.

Blog Feed

Understanding the Differences in Processing Aids and Additives for Medical Devices

When preparing regulatory documentation, distinguishing between processing aids and additives can indeed be challenging. According to...

FDA draft the new guidance document "Chemical Analysis for Biocompatibility Assessment of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff"

The FDA released a draft guidance document titled "Chemical Analysis for Biocompatibility Assessment of Medical Devices Draft Guidance...

Key Changes of ISO/DIS 10993-1:2024, are you ready?

About Us

Our Commitment to Excellence

At GK Medtech, we are dedicated to accelerating medical device and material innovation through scientific expertise. Specializing in medical device material development, regulatory submissions, biological risk assessment, biocompatibility strategy, and chemical characterization, our services empower clients to efficiently and responsibly bring innovative medical solutions to market.

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