Project Management

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 […]
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 […]
July 11, 2017
Medical Device Development - Quality Engineering

The Second Pillar of Medical Device Engineering: Creating an Effective Quality System

In our last blog, we explored Design Control – the first of three pillars that support quality medical device development. The second pillar is the creation of a Quality System. This pillar is instrumental in meeting regulatory requirements to FDA and CE Mark agencies requiring compliance to ISO 13485 – Medical Devices Quality Management System and ISO 9001 – Quality Management System. Regulatory entities require that the framework of a quality system be compliant to […]
June 21, 2017
Design Control is the first pillar of quality medical device engineering.

The First Pillar of Quality Engineering for Medical Devices

One aspect of REV.1 Engineering that sets us apart from many product design firms is the experience we have working within medical device quality systems. With years of experience at companies such as Abbott Vascular, Boston Scientific, Edwards Biosciences, Volcano/Philips, and many start-ups, our engineers and technicians understand how to work efficiently while still following necessary design controls. While we let quality medical device engineering guide our thought process, we do not let it become […]