August 3, 2017
Carlsbad, CA medical device companies

Attention Carlsbad Medical Device Companies: Discover Murrieta Research & Development Services

If your company is based in Carlsbad, CA and you are looking to outsource your medical device development, look no further than REV.1 Engineering in Murrieta. You are invited to visit our state-of-the-art facilities and meet with our team about your latest medical device project. Whether you have a napkin sketch of an idea or a prototype that you can’t seem to move to the next phase, we are ready to get started today. Our […]
July 31, 2017
Foothill Ranch CA Map

Foothill Ranch Medical Device Development: Rapid Transformation from Prototype to Commercialization

Getting a new medical device product to market is a challenge. If your company is located in Foothill Ranch, read on to learn more about REV.1 Engineering, a top outsource solution for medical device development located in nearby Murrieta. Our streamlined and effective product development and project management process operates in a unique and proprietary ecosystem that has moved our clients’ medical devices from napkin sketch to prototype to manufacturing. Your Dedicated, Experienced Team With […]
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 […]
July 25, 2017
Mitigate medical device development risk.

Medical Device Development: Five Risks

In the feasibility phase, all aspects and options for design should be researched and explored, which will avoid wasting time and spending more money in the back end when problems require “do-overs.” Here are the five primary risks to mitigate prior to design freeze (click to read the complete article): 1) Team: Be sure your team has the two most important qualities: Experience and breadth of skill. An inexperienced team will often find themselves deep […]