Since starting my career in the medical device industry over 15 years ago, there have been a few constants. One of these constants is that many medical device product developers loathe Design Controls. Many of the comments I’ve heard over the years have claimed that Design Controls often hamper and slow down product development. And nearly anyone who has worked with existing product development processes at a medical device company seems to cringe at least a little at the mention of “Design Controls”.
Let’s just say there are very few individuals I’ve encountered during my career who are genuinely excited about Design Control documentation, processes, forms, etc. I’ve perceived actually that there is a fair amount of “pain” felt regarding this topic.
It’s because of this pain that has led me and a small software team to find a better way. This better way is called greenlight.guru. Our team has had there head down for the past few months developing this tool. On April 1, we are releasing a “sandbox” to a group of early adopters who can also start to learn about the better way of documenting, collaborating, and managing Design Controls and Design History Files.
I’ve had a chance to play in this sandbox before releasing it. I’m VERY excited about how UniDoc works and the impact I know it will make in the medical device industry.
Do you want to be a part of a new Design Control experience? Contact me and let’s figure out how to make this happen.