Medical

At Inspectra Edge, we empower medical device manufacturers to meet global safety and quality standards with confidence. Our expertise ensures your innovative devices reach the market efficiently while complying with complex regulatory requirements.

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Streamlining Compliance for Medical Devices

Bringing medical devices to market requires navigating stringent standards such as FDA guidance, IEC 60601-1, and other international regulations. Inspectra Edge offers tailored solutions to simplify this process, ensuring your devices meet safety, performance, and compliance criteria for faster global entry.

Our services cover every stage of medical device development, from testing and certification to quality assurance. Whether you’re launching groundbreaking technologies or enhancing FDA-approved devices, Inspectra Edge provides the expertise you need to succeed.

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Our Solutions for Medical Device Manufacturers

Regulatory Expertise

We help you navigate global regulatory frameworks, including:

• CB Scheme
• FDA Guidance
• ASCA and NMPA Requirements
• Compliance for regions like Japan, Brazil, and more.

Advanced Testing and Validation

Ensure the quality and performance of your medical devices with our comprehensive testing services, including:

• Electrical Safety and EMC Testing: IEC 60601-1, 60601-1-2, and home healthcare standards.
• Performance Testing: Battery testing, biocompatibility, reliability, benchmarking, and Reese’s Law compliance.
• Specialized Equipment Testing: For implantable devices, medical imaging, and wireless technologies.

Focus on Innovation

We support emerging technologies like:

• Software as a Medical Device (SaMD)
• AI-Enabled and Machine Learning Devices
• Connected and Wireless Medical Technologies

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End-to-End Support Across the Value Chain

Inspectra Edge provides a global network of scientists, engineers, and regulatory specialists to address your challenges in safety, quality, and compliance. Our services include:

• Auditing and Certification: In-depth reviews to meet global regulations.
• Materials Testing and Chemical Analysis: Ensuring safe and compliant materials.
• Clinical Trials: Robust, GCP, and ISO 14155-compliant trials conducted by multidisciplinary teams.

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Your Trusted Partner for Medical Device Success

The medical device industry faces complex challenges, but with Inspectra Edge by your side, you gain the assurance and expertise needed to meet global standards and launch your devices successfully.

Choose Inspectra Edge for reliable solutions that drive innovation and compliance in medical device manufacturing. Together, we’ll advance healthcare worldwide.