Category Archives: greenlight.guru

Importance of Medical Device Design Controls – Part 2

Read part 1 of Importance of Medical Device Design Controls. Now for part 2 . . . If you evaluate the regulatory trends and hot topics, Design Controls usually makes it into the top five. However, the current culture of the medical device industry rarely push Design Controls to the top. Rather, topics like Complaint Handling, Corrective & Preventive Action (CAPA), and Risk Management often dominate medical device industry blogs, conferences, and hot topics. This is somewhat justified due to the focus and attention regulatory bodies across the world have paid to these other important elements. Let me take a few moments to talk a little about each of these other topics with respect to Design Controls. Complaint Handling pertains to medical device product issues and failures....

Importance of Medical Device Design Controls – Part 1

Is medical device product development really all that different than product development of other products and technologies? If you take a moment to really think about this, the answer is not all that easy to address. From one perspective, no, the medical device product development process is by and large just like any other product development process. Sure, some of the work products and deliverables and regulatory requirements are different. But overall, the process is the same (or at least it should be): establish a business case, capture user needs, define requirements, figure out how to build it, prove that it is safe, prove that it works, prove you can make it. From another perspective, yes, the medical device product development process is vastly different than other product development processes. Why? Regulations,...

Is Spreadsheet for Design Control Traceability a Best Practice?

What tools are you using to ensure traceability of your medical device Design Controls? How do you show that your Design Outputs meet your Design Inputs? How do you link Design Verification? How do you show that you Validate your User Needs? Demonstrating traceability of your Design Control activities is not only important--it's necessary. A best practice I've observed is the creation of a wonderful spreadsheet to show traceability. Each column represents a different Design Control element--User Needs, Design Inputs, Design Outputs, Design Verification, and Design Validation. Showing how one links to the other is the purpose. Yes, I'm a fan of spreadsheets. I often dream about them.  Yes, I've used spreadsheets for Design Control traceability countless times. Despite this, I think using a spreadsheet for Design Control traceability does have some shortcomings.
  • Spreadsheets are...

I’m Buying UniDoc

Maybe by now you've read some of my blog posts about UniDoc. UniDoc is the collaborative way to manage Design Controls for all your medical device projects. We're working hard towards a launch in early 2014. As part of the this launch, we are seeking 5 medical device companies to get on board and take advantage of special pricing. If you would like to be one of these companies, let me know. Interestingly, Creo Quality is working with a startup medical device company who could benefit from UniDoc right now. Actually, we could have used it a few months ago. But now is better than never. It's because of this that I made the easy decision to make the UniDoc purchase. That's right. I...