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Neo Tech Beat

How Medical Device Design Plays A Critical Role In Time-To-Market

At NEO Tech, we understand the extremely demanding process of obtaining approval for a new medical device. In our experience in working with OEMs and companies in the medical device industry, we have developed services from medical device design through to contract manufacturing to assist in accelerating the process of concept to market.

The speed of time-to-market plays a critical role for the OEM. The months and years in design, testing, prototyping, and approval is time without any income from the device. The shorter this period is, and the more accurate each step in the process is completed, the faster the OEM is able to start seeing a profit and recoup their investment.

Understanding Regulations and Requirements

With our specialization in medical device design, our team has a full understanding of the different classifications of medical devices and the relevant regulations. This ensures the design is fully compliant with all requirements for safety features to the choice of the most appropriate materials for production.

Providing Necessary Documentation

While there are many different companies offering medical device design, without extensive experience in documentation and verification of all stages of the design process, delays and issues can occur. Through our experience and expertise, we will ensure all required documentation is available for the approval process.

Using Technology to Your Advantage

The use of state-of-the-art software and engineering design programs allows our team of engineers to design and complete virtual testing on all of our design elements. With this technology in place, the design phase can be streamlined, ensuring the project will stay on schedule.

Move To Manufacturing

Once approved, we are prepared to move into full production as your contract manufacturer. This will ensure full quality control through our ISO 13485, FDA registered and 21 CFR Part 820 compliant systems.

To learn more about the benefits of using NEO Tech for your device design and contract manufacturing needs, call us today at 818-495-8617.