design engineering process

The recent IEC 62304 standard has gotten a lot of hype lately, as manufacturers throughout the medical industry grapple with what is quickly becoming the industry go-to for medical device software development. The FDA has adhered to the standard since 2008, and it has become normative for CE marking in recent years as well.

Medical manufacturing is one of the fastest-growing manufacturing industries, but it’s certainly not without unique challenges.

At ControlTek, our entire design engineering, project management and contract manufacturing teams are all highly experienced with the often complex requirements as identified by the FDA.

At ControlTek, we have a shared passion for helping our customers bring new and innovative products to life. From design to production, ControlTek has developed the processes that take new product designs through production and onto market quickly while also ensuring quality production and cost-efficient management of manufacturing resources.

ControlTek’s new product introduction process includes the kind of transparent, open communication that’s become our signature, offering us the unique opportunity to become a partner rather than a vendor.

EMS Testing is one of the most important aspects of any electronics manufacturing project. During the course of product development, testing ensures that all product requirements are met and high quality products will be delivered.

When choosing an EMS test strategy, it’s important to get involved as early as possible in the design process. By considering testing early on, ControlTek can help you get better test coverage while reducing EMS testing costs and speeding up the testing process.

At ControlTek we understand that successful production begins with a well-defined design engineering process. ControlTek customers don’t just need a finished design; you need a finished design that offers a feeling of security, knowing that the end product will meet your requirements and withstand rigorous testing and end use.

"The design and implementation of NACCO Material Handling Group's electronic transmission controller has been a success due to ControlTek's proven design process and their commitment to achieving customer product goals. Their easy to work with engineers have demonstrated that they have the skills and commitment to create successful products."

- Alan Reece, Engineering Manager, NACCO Material Handling Group
www.nmhg.com