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 […]
July 20, 2017

What’s Slowing Down Your Medical Device Development in San Clemente?

When it comes to finally getting that idea for a great new medical device into production, the faster you can move, the better. Even if you are an established San Clemente firm, sometimes you need a helping hand with a project that requires specialized engineering skills, or maybe your in-house team just has too much on their plate to take on something new. REV.1 Engineering, based in nearby Murrieta, is a medical device research & […]
July 17, 2017
Don't miss an opportunity!

Low Fixed Rate Bid: Lost Opportunities in Medical Device Development

Selecting your R&D team will make or break your medical device development project. And whether you’re a start-up or an established company looking to supplement an existing team, cost is always a factor. You want to keep costs down – but don’t forget, you also need to keep your productivity high. We’ve been the “rebound” R&D development firm for more than one client who thought they would save money with a low fixed-rate bid. They […]
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