General Discussion

What questions do you have on EUMDR? Drop them in the thread below and we’ll make sure they are addressed on the call with Chandler!

AMA on EUMDR with Chandler Thames

9 days ago

Tim HickleDirector of Content and Community

Hey everybody!My name is Tim Hickle and I’m our Director of Content and Community here at Greenlight Guru. You are going to see me from time-to-time sharing content and sharing moderating duties with our world-class Community Manager, Etienne.I wanted to start a thread where we can introduce ourselves and share the human side of our community.A little about me: I’m a born-and-raised Hoosier (That means “Person from Indiana” for those of you not from the States) who loves basketball and a good nonfiction book. When I’m not working or parenting, you’re likely to find me listening to a podcast or watching Ted Lasso. My wife is named Kristen and we have an almost-two-year-old named Myles who is NOT the most efficient co-worker I have, but who is definitely my favorite. Feel free to share a little bit about yourself, your interests, hobbies, and family! Whatever makes you, “you!”

Meet The Community - Introduce Yourself!

18 days ago

EtienneCommunity Manager

Between Product Development and Quality Assurance, there are a few tasks related to Design Controls that are done by… Design Assurance. Whether or not they where the title, the functional owner of most Design Controls tasks need to be able to toggle between Product Development and Quality - it’s a unique hat (or set of hats) to wear. We hope this discussion is helpful as you approach the Roles and Responsibilities of someone working in Design Assurance! Thanks,@Etienne

AMA on Design Assurance with Orla Connaughton

18 days ago

EtienneCommunity Manager

RoundTable on Clinical AffairsWhat are the things you're struggling with when it comes to clinical affairs and your device? What aspects of this topic would you love to hear the industry experts dive deeper on? Let us know in the comments below and we’ll make sure it’s mentioned!Make sure you RSVP to our live RoundTable discussion on Sept. 28th!

RoundTable discussion on Clinical Affairs

26 days ago

EtienneCommunity Manager

Let’s talk packaging & sterilization! I don’t know about you, but this is one of those topics that some manufacturing and product development engineers try to push to the bottom of their priority list, and “kick the can down the road” until they absolutely HAVE to address it. Which can quickly turn into an “all hands on-deck” situation.Instead of putting it off, let’s talk about all your packaging and sterilization questions.EDIT: I just found out that Roy (our expert) will be unable to make it, and with the Virtual Summit going on right now I’m not able to get a back up expert on Packing and Sterilization… SO! If you still have specific questions, please drop them in the comments below, and I will make sure they are answered by the end of the week!Thank you for your patience and especially your participation!All the best,Etienne Nichols

AMA on Packaging & Sterilization

29 days ago

EtienneCommunity Manager

We invited Greg Lyons from LGD Ventures for an exclusive AMA (ask me anything) session to talk Supplier Management! If you have run into problems, send a message directly to @Etienne and let us know!

AMA on Supplier Management

asked in Ask Me Anything (AMA) sessions

PaulQSCNew Participant

OEMs and Distributors

Do OEMs and Distributors need to be on the “Approved Supplier List?”

EtienneCommunity Manager

We invited Shannon Hoste from Agilis for an exclusive AMA (ask me anything) session to talk Combination Products. If you have run into problems, send a message directly to @Etienne and let us know!

AMA on Combination Products

EtienneCommunity Manager

Thank you all for the discussion in our RoundTable discussion of intermittent SaMD Validation of Cloud Platforms!If you missed the discussion, you can view it below:If you have run into problems, send a message directly to @Etienne and let us know!

AMA on Cloud Validation

EtienneCommunity Manager

We invited Kyle Rose from RookQS for an exclusive AMA (ask me anything) session on the topic of the recent the IVDR.If you have run into problems, send a message directly to @Etienne and let us know!

AMA on IVDR

EtienneCommunity Manager

We invited Gary Saner from Reed Tech for an exclusive AMA (ask me anything) session to talk UDI.Please let us know if you have any issues accessing the recording. We hope this was a beneficial session and we’re looking forward to seeing you next week! All the best,Etienne Nichols

AMA on UDI

EtienneCommunity Manager

This week we’ve invited Jody Birks from the Eagle Medical for an exclusive AMA (ask me anything) session on Sterilization.If you’re not signed up yet, be sure and RSVP here.What challenges are you currently facing as you work through your sterilization process? What feels unclear?Ask us anything!Leave your questions in the comment section below - this will give your question the greatest likelihood of being answered.P.S. There is an interactive video element to this AMA that you can participate in. The link to join the Zoom meeting will be provided on the day of the event!If you have run into problems, send a message directly to @Etienne and let us know!Link to Zoom meeting.

AMA on Sterilization

EtienneCommunity Manager

This week we’ve invited Shawn Findlater from the VirtualQE for an exclusive AMA (ask me anything) session on ASQ Certification.If you have run into problems, send a message directly to @Etienne and let us know!

AMA on ASQ Certification

EtienneCommunity Manager

What do you think so far of our community? Isn’t it so adorable, it’s my baby, and I love it so much… But I want it to be YOUR community, so please give any and all constructive feedback!What do you think of the topics? How was the intro email? Is there anything missing that you expected? Are there any things you would change with the usability or navigation so far? What did I miss??I know you’re busy, but I want to hear it all - tell me now so I can make your life easier later!Thank you!

Community Feedback!

EtienneCommunity Manager

Welcome to the community, everybody! 👋🏼I want to help you get the most out of the community, so check out the Getting Started page.Also, feel free to introduce yourself here - I’d love to hear more about what you do and what your goals are! This is your cohort of new members, so that automatically makes you friends, right? 😂I look forward to getting to know you! @vesone, @KrzysztofNazar, @keliyew, @odejesus, @vanessashebola, @Greg Lyons, @BenB, @TrueQuality2022_Eli, @JimSkinner, @jjmifsud, @mattdneal, @Chris, @Namratha Kumara

Welcome our New Members!

EtienneCommunity Manager

DId you know you can follow a member? Have you run across someone whose posts are consistently great? You can essentially subscribe to that persons posts within the community by clicking on their name, which will take you to their community profile) and clicking “Follow Member.” You’ll be notified whenever they create a new post or respond to existing posts. Did you know you can subscribe to a category? Let’s say you are particularly interested in Clinical Investigations, but there hasn’t been much activity in that category…. You can subscribe to that category! When you navigate into any category of the community, at the top right is a button that says, “Subscribe.” When you do that, you will be notified of all future posts within that category. Did you know you can change your username? We can do this on the back end, so if you’d like to change your username, reach out to community@greenlight.guru or simply direct message@Etienne. (Oh yeah - you can direct message pe

Community Quick Tips, Vol. 1

EtienneCommunity Manager

This week we’ve invited Ben Bancroft from Greenlight Guru for an exclusive AMA (ask me anything) session on the topic of Root Cause Analysis.If you have run into problems, send a message directly to @Etienne and let us know!

AMA on Root Cause Analysis

EtienneCommunity Manager

Every Wednesday we host in industry leading expert to answer all of your burning questions. We call these AMA (Ask Me Anything) sessions… And since they are held on Wednesday, it’s WAMADay! This weeks topic is over the Contract Manufacturing and is with Mark Rutkiewicz, founder of Consiliso: Medical Device Company In A Box. After 30 years in the industry, Mark Rutkiewicz is well known for fixing Quality Systems in all sizes and types of medical device companies. And even more known for moving beyond compliance-focused functions and fixing all the other business process and information sharing issues across the company.We hope this is a valuable, interactive session that is able to help you with the challenges you are currently facing!If you have questions about the format, please send a message to @Etienne and let me know!

AMA on Contract Manufacturing & Supplier Management

EtienneCommunity Manager

This week we’ve invited Aaron Lucas from the Greenlight Guru Academy for an exclusive AMA (ask me anything) session on the topic of the recent Academy Advance launch. Link to the Zoom call.Leave your questions in the comment section below - this will give your question the greatest likelihood of being answered.P.S. There is an interactive video element to this AMA that you can participate in. The link to join the Zoom meeting will be provided on the day of the event!If you have run into problems, send a message directly to @Etienne and let us know!

AMA on the Academy

EtienneCommunity Manager

This week we’ve invited Jón Ingi Bergsteinsson & Páll Jóhannesson from Smart Trial for an exclusive AMA (ask me anything) session on the topic of the Clinical Investigations.If you have run into problems, send a message directly to @Etienne and let us know!

AMA on Clinical Investigations

EtienneCommunity Manager

This week we’ve invited Anne Holland from QA Consulting for an exclusive AMA (ask me anything) session on the topic of the FDA Inspections.Zoom LinkWhat challenges are you currently facing as you prepare for your audits and FDA inspections? What feels unclear?Ask us anything!Leave your questions in the comment section below - this will give your question the greatest likelihood of being answered.P.S. There is an interactive video element to this AMA that you can participate in. The link to join the Zoom meeting will be provided on the day of the event!If you have run into problems, send a message directly to @Etienne and let us know!

AMA on FDA Inspections

EtienneCommunity Manager

This week we’ve invited Michelle Lott from LeanRAQA for an exclusive AMA (ask me anything) session with the community concerning the topic of anything related to your Regulatory Strategy!If you have any feedback or suggestions, send a message directly to @Etienne and let us know!

AMA on Regulatory Strategy

EtienneCommunity Manager

This week we’ve invited Mark Swanson from QRX Partners for an exclusive AMA (ask me anything) session with the community concerning the topic of the Risk Management.We hope this is a beneficial session for you!If you have any questions, send them to @Etienne!

AMA on Risk Management

EtienneCommunity Manager

We invited Russ Branaghan from Research Collective for an exclusive AMA (ask me anything) session to talk Human Factors.If you’re not signed up yet, be sure and RSVP here.What challenges are you facing with your Human Factors project? What feels unclear?Ask us anything!Leave your questions in the comment section below - this will give your question the greatest likelihood of being answered.P.S. There is an interactive video element to this AMA that you can participate in. The link to join the Zoom meeting will be provided on the day of the event!If you have run into problems, send a message directly to @Etienne and let us know!

AMA on Human Factors