Medical Devices

We can help you turn your idea into a successful product with our innovative engineering approach and thorough understanding of the strict medical regulatory environment.

Let Us Help You Overcome Your Hurdles

NEW PRODUCT DEVELOPMENT FROM CONCEPT TO PRODUCTION

Syncroness can help you reduce your time to market by employing our systems engineering approach to complete projects for you, or by integrating with your team to increase your capacity. Working with Syncroness gives you the benefit of access to our technological experts, increasing your capabilities.

PRODUCT DEVELOPMENT PROCESS EXPERTS

Our Project Managers are skilled at directing projects to ensure that the planning and execution of projects meet your expectations. They collaborate with our Systems Engineers to capture all the relevant details related to your project including requirements, behavior, architecture, risk, and testing of the system. Specifically, we specialize in:

  • Rapid Prototyping and Iterative Design
  • Verification & Validation planning, execution, and reporting
  • Fabrication and Validation of Clinical Test Units
  • Regulatory Submission (FDA, CE, etc.)
  • Transfer to Manufacturing

ENHANCEMENT AND MAINTENANCE SUPPORT FOR EXISTING PRODUCTS

When components go end-of-life or new functionality for existing products is required, we can help you make the necessary updates. Allowing us to take on these projects frees up your valuable internal talent to work on new product development, innovation, and research.

CUSTOM AUTOMATION EQUIPMENT TO MEET YOUR ASSEMBLY, TEST, OR CALIBRATION NEEDS

We are adept at developing the custom production equipment that allows you to save time and money by automating critical processes. We can also develop production equipment parallel with your product design, which can reduce total time and cost, and shorten your new product development time.

Areas of Expertise

FROM BREAKTHROUGH TO FINISHED PRODUCT

You’ve struck on an innovative idea or made a scientific discovery. We can elaborate on your idea and turn it into a marketable product.

EXCEL IN
COMPLEX DESIGN

Our teams love tackling problems that haven’t been solved before. From new technology to performance improvements, we are motivated by challenging problems.

DESIGN FOR
ENVIRONMENT

It’s one thing to create a functional medical device, it’s another thing altogether to make sure that it performs in the demanding environment it is intended for. From UX to durability, we can make sure the product hits the mark.

SUBMISSION-READY DOCUMENTS

Navigating the regulatory process for medical device can be very complicated. We’ve helped many of our customers through it, and can make sure that your submission process is smooth.

You get more with Syncroness.