August 10, 2017

Speed Your Medical Device Development with In-House Machining

When in-house machining is not an option, medical device engineers are forced to use outside companies for quotes and machining. Typical turnaround times can run from 2 to 6 weeks, depending on the complexity of the piece. And then what happens if the outside machining company gets it wrong – or if it turns out your specifications were not exactly right? Then you are waiting several more weeks to get a part you needed at […]
August 15, 2017
Full Time Equivalents in Medical Device Development

10 Heads for the Price of 2: Medical Device Development on Hyperspeed

Whether you have an established medical device business or are starting up a new company, staffing efficiently is always a challenge. There is always a limit on how many engineers and staff positions you can fund, and the wide array of skills necessary over the course of developing a medical device often requires dozens of separate skill sets: • Head of R&D • Program/project manager • Engineers: Design, clinical, quality control, electrical, mechanical • Technicians […]
July 27, 2017
REV.1 Engineering 3 Pillars of Medical Device Development

The Third Pillar of Medical Device Engineering: Compliance Certification

So far we’ve discussed two of the three key pillars of quality medical device engineering: Design Control and Quality System. The third, Compliance Certification, is the audit of the design controls and quality system, and is therefore heavily dependent on successful implementation of the first two pillars. Many medical device companies feel anxious when it comes to certification – and for good reason. While everyone is aware of the long check list the certification agencies […]
August 8, 2017
Irvine, California Great Park: Palm Court

Irvine Medical Device Development: The Choice Is Yours

You’re located in Irvine and you have sketched out a great new medical device idea. Maybe you are a start-up, but more than likely you have an established company and your current R&D team simply doesn’t have the band-width or special skills needed to bring your idea to life. Selecting a medical device engineering team to work with your existing Irvine team may seem daunting – but look no further than Murrieta, where REV.1 Engineering […]