General Discussion

Something on your mind? Use this space to get other peoples thoughts on the matter!

  • 7 Topics
  • 5 Replies

7 Topics

Etienne
EtienneCommunity Manager
posted in General Discussion

New to Greenlight Guru? Check out these helpful resources

Have just registered with Greenlight Guru and would like to understand what’s the best way to begin your journey with us? Since you’re reading this, you’ve already done the first step and we’re happy to guide you further!  For those who have recently started exploring Greenlight Guru, we have helpful resources in our Help Center. Go to the pages below:Implementing a New Quality Management System to see how you navigate on your dashboard   How to Prepare for and Drive Successful Audits Using Greenlight Guru to get more details about opportunities provided by Miro board tools such as  and many others -  we hope you’ll be surprised!   How to Achieve Collaborative, Continuous Medical Device Product Development with Greenlight Guru Products eview the best practices for working on the board   How to Manage, Organize, and Find Your Documents With Ease to add the magic of collaboration to your workflow   Master Documenting Design Controls with Greenlight Guru to discover functionalities suppor

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Etienne
11 months ago
Etienne
EtienneCommunity Manager
published in General Discussion

What is your favorite MedTech software?

For brainstorming: 💥 Strategy💥 I mean the software. we like sticky note and whiteboard sessions, but nobody likes inputting the mess back into Excel afterwards. It takes weeks... (Eh, what else do we pay Project Managers to do, amirite?) Instead, what if your team could asynchronously put those sticky notes into an Impact/Effort table, and turn it into a list with weighted scores (or tag them to become User Needs or Design Inputs later) automagically? Strategy does that, and a lot more. Specifically built for cross-functional MedTech teams. Plus there's an option for early access. Link in the comments.   For physical design: 💥 Solidworks💥 I know, mechanical engineers are biased - but I've searched microfilm, NX Ideas, AutoCAD, and paper drawings... Those are hours of my life I'll never get back. SolidWorks beats them all. Plus, in 2021, when I had nothing more than an idea and an LLC, but SolidWorks gave me a free year of Pro + Simulation... Yeah, I'm biased... And their Entreprene

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Etienne
2 months ago
radhikapandya
radhikapandyaEmployee
posted in General Discussion

2023 MedTech Industry Benchmark Survey

Hello MedTech Community! I need your help. Take part in this industry survey  for medical device executives, QA/RA, and product development professionals to help us uncover trends and day-to-day operations of successful medical device companies worldwide. The survey should take less than 10 minutes to complete and all answers are kept completely anonymous. In return for taking the survey, you can receive free, early access to the research report before it’s released to the public. You can also enter your name into a drawing to win our prize of $100 for you, $100 to give. Donations will be made to Project Cure in the winner’s name.Click here to get started!  

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Etienne
5 months ago
Etienne
EtienneCommunity Manager
posted in General Discussion

Let's read this book, "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List"

 A friend of mine gave me this book by Howard Root, Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List. So far I’ve been impressed with how easy the book is to read - but it also goes into detail about things like indications for use vs. intended use, and off-label promo vs. off-label use… And how to prepare both your company and yourself to go to trial and defend both your device and how it was developed and marketed. This book will expose you to the sides of a medical device company that most of us do not think about very often, but will likely have to interact with at some point.I thought it would be fun if some of us read the book together and then tried to get Howard on for a live podcast!Here’s a link to Amazon if you want to get the book. Love to hear any thoughts you all might have!

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Etienne
5 months ago
Niki
NikiEmployee
posted in General Discussion

Phone App in 510k

How do I add details about the phone application into the 510k for a medical device? Any best practices?

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Etienne
7 months ago
Etienne
EtienneCommunity Manager
posted in General Discussion

Why are you a medical device professional?

Hey everyone! We recently sent out postcards to all the employees with the following “fill-in-the-blank” statement for them to complete:“I am committed to improving the quality of life because __________ “I’ve been staring at the postcard for awhile, and FINALLY came up with an answer. It made me curious though… The medical device industry can be a real grind… it takes a long time to get to market, compared to other industries. Things can move slow, and be incredibly stressful because much of what you do could eventually be examined by a government official. So, my question for everyone is….Why are YOU in this industry? 

1
E
11 months ago
Etienne
EtienneCommunity Manager
posted in General Discussion

MD&M West

Hey everyone!I’m heading to Anaheim, CA for the MD&M West conference, April 12-14th… It’s apparently the largest design & manufacturing conference in North America, so I’m looking forward to seeing the new technology that’s out there.If you happen to be in the area () you can use the discount code “SPEAKER” for 15% off the ticket price!Ok, let me get to the point...I was asked to speak on a panel on the topic, “Resources for the Busy Entrepreneur.” The topic made me curious what kind of suggestions you all might have. What resources do you consider indispensable? Love to hear your thoughts!

0
Etienne
11 months ago

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