ABOUT AIRTRUST MEDICAL DEVICE SERVICES

Airtrust medical service helps emerging and established firms commercialize novel and innovative medical devices, including in vivo device, in vitro diagnostics and combination medical products in China. Since we began operations in 2001, clients have turned to us for strategic consulting and tactical solutions to understand and overcome Chinese regulatory, compliance, and clinical trial challenges at all stages of the medical product lifecycle.

With Airtrust you have access to a team of consultants and project managers with a wealth of Chinese State Food and Drug Administration (SFDA), industry, and healthcare experience to guide you through product local sales and marketing development and product launch, and to help you ensure post market product compliance.

Small entrepreneurial firms drive innovations in medical technology, but often struggle with limited funding and inadequate resources. A recent AdvaMed industry report identifies US FDA regulatory requirements and the cost of clinical research as two of the most significant factors affecting a company's ability to develop new medical technologies.

These challenges are especially daunting for start-ups focused on breakthrough medical technologies that will establish new markets based on novel clinical indications, new procedures, or new patient groups. If you are seeking to launch your device into the Chinese market, Airtrust is a vital partner to help you throughout your product development process. Our experts will help you to identify, understand, and overcome regulatory and clinical trial obstacles, avoid costly design and development delays, and speed your journey from product concept to commercialization.

In today's global marketplace, the development and marketing of medical products is a highly regulated process with strict governmental requirements. Since 2001, Airtrust has provided regulatory, clinical, and quality assurance consulting services to help medical device, in vivo device and in vitro diagnostic product manufacturers meet those requirements.

By leveraging Airtrust's comprehensive knowledge of SFDA and regulations, you can capture and grow market share, increase productivity, and stay competitive in an increasingly complex global marketplace. Whether you need to define your regulatory pathway, support your product with a well-designed clinical trial, prepare your team for an SFDA audit, or ensure ongoing compliance, Airtrust has the experience and knowledge to lead you to success.