medical device manufacturing

As a supplier of medical electronics, ControlTek is working closely with medical customers to quickly ramp up production of critical care medical devices.

Maxtec Oxygen Analyzers

ControlTek's partner and essential business, Maxtec, is one of just a few U.S. makers of medical oxygen sensors and oxygen analyzers used in hospitals around the globe. Maxtec has been a leader in oxygen analysis and delivery for over 20 years.

Hosted by the SMTA, the 2016 Medical Electronics Symposium will take place at Marylhurst University just outside of Portland, Oregon on September 14th and 15th. This marks the second year that the Symposium will take place in the Portland Metro area. Previous Symposium events have been held at locations in Arizona and California.

ControlTek’s V.P. of Marketing and Human Resources Stacey Smith returned home last week from the 2016 IPC APEX Expo flush with new ideas and loads of great new information about new trends expected within the EMS industry in the next few years. We checked in with Stacey to get her Top 5 takeaways from this year’s event:

The annual IPC APEX EXPO is coming up March 13-17 in Las Vegas, Nevada, and as usual the lineup of events, speakers, and technologies promises plenty of exciting options for attendees. ControlTek's Stacey LaFrazia Smith will be headed to the City of Lights to attend the EMS Executive Roundtable Monday, March 14th.

Medical device manufacturing has traditionally been a challenging undertaking. FDA regulations are not only complex, they can also change dramatically from one project to the next. In a new article, ControlTek President Andy LaFrazia helps readers tackle these and other issues specific to Medical Device Manufacturing.

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.

Many of our customers are familiar with the challenges of getting medical products to market--tight FDA regulations for medical devices often means additional measures such as hazard risk assessment, testing and part validation--but not everyone knows that medical device test fixtures also need to be tested, or just how important it is to ensure your products undergo thorough documentation during design and testing processes.

From initial research and development to testing and documentation, ControlTek’s services can provide assistance at any stage of your medical device development. Our FDA registered facility and ISO 13485 certified quality system provides an audited environment that meets FDA requirements and includes services such as medical electronic design (circuit, mechanical, PCB layout and more), product and pcb prototyping, and test design.

Following on the heels of our recent investment in a Juki FX-3 Surface Mount Technology System this year, ControlTek has just added two new Heller 1809 MKIII Reflow Ovens and a 3 chamber Trident LD Automatic Defluxing system to our production facility. The new equipment provides additional speed and flexibility during changeovers as well as enhanced product reliability from contaminant-free manufacturing processes.