Tag Archives: product development

Providing FREE Design Controls Guidance

When we started greenlight.guru, the initial mission was this: Develop a software solution to help medical device companies with Design Controls. I'm thrilled to report that we have done just that -- and more. The current product does include an easy to use Design Controls module. The product also includes a module for Document Management, so that you can store, review, approve, and revise all your critical documents and records in a secure, cloud-based application. The interesting thing about this journey has involved more than just providing a software solution. It's about helping medical device professionals in getting their products to market faster, while helping ensure regulatory compliance. If you have read any of my previous posts, you probably have noticed my passion and interest in the topic of Design Controls. Why? Because throughout my nearly 17 year career,...

Design Validation proves you rocked it

Last time, I shared that Design Verification is all about designing your medical device correctly. What about Design Validation? Design Validation is proof that you have the correct medical device. What do I mean by this? Design Validation demonstrates that the medical device you developed meets the needs of the end user. It is a critical step in the Design Control process.

The role of User Needs

Without a doubt, the user needs for your medical device product development project have a significant impact and relationship on Design Validation. Keep in mind you capture user needs at the beginning of a project (or at least you should). User needs are a way to express what is important about the medical device from the perspectives of the doctors, nurses, clinicians, and others who will use your...

Project Management Chaos

Project management is a key to successful medical device product development. Sounds cliche, I know. But it is true. When project management is good, you know it. And of course, when project management is bad, you know this too. The trouble is we all experience poor project management more often than good project management. When you hear the term "project management", what thoughts come to mind? I suspect you instantly think of things like work breakdown structuresGantt charts, and MS Project. You might also think of organizations like the Project Management Institute and the PMBOK. Yes, these are all pertinent references for project management. When I refer to "project management", I'm referring to something more basic. I'm referring to a process of getting things done.

Project Management Certification?

I think...

Design Control Software Simplifies Medical Device Development

You may be aware that I have been involved with the design and development of a Design Control software solution. I'm happy to report that we have released this software and currently have a fantastic product ready and released. The product is greenlight.guru. [caption id="attachment_6563" align="alignnone" width="300"]greenlight.guru Design Control software simplifies greenlight.guru Design Control software simplifies[/caption] I have a really great deal for you right now too. But you need to contact me to learn more about the greenlight.guru Turkey Day Special deal. Read on below to discover why this matters to you.

Origins of a Design Control software solution

Why did I have the idea to create a Design Control software solution? I can't exactly pinpoint the day, but I can recount many of...