Ask Me Anything (AMA) sessions

We’re planning to hold AMA (Ask Me Anything) sessions every week for the next 6 weeks (until forever?) My question to you is… What topics are you interested in? Here are some that came to mind for me…BIocompatibility UDI EUMDR Cybersecurity 3D-printing Risk Management (14971) QMSR (FDA QSR alignment with 13485) Combination ProductsOr, are there certain guests that you would like to have an AMA with?Comment below and let me know!

Tell us what topics you'd like to see in future AMA's!

8 months ago

EtienneCommunity Manager

Here’s the video to this weeks AMA session!

AMA on IEC 62304

EtienneCommunity Manager

Roy, thank you for sharing your expertise with us on Packaging & Sterilization! His last piece of advice was really good - fail early, fail often, and fail cheap. We could stand to apply this to how we build out our packaging activities! I hope you enjoy this conversation with Roy!

AMA on Packaging with Roy Morgan

Brian MatcheskiParticipating Frequently

@Keith Kallmes @EtienneThanks for hosting the AMA session today! One question that I wanted to ask during the session was about the age of literature used in a CER. New research is great, when available, but what If one finds a high quality article published in a journal, say 10+, 20+ years ago. How can you frame the article to support its current relevance? and how old is too old for literature to include it in a evaluation report?Thanks,Brian

Follow up question from the AMA-Clinical Evaluation Reporting

EtienneCommunity Manager

Thank you to everyone who participated in the AMA on Quality Leadership with Mike Baca from White Rook Consulting! Great conversation, and if you were not able to attend, I highly recommend watching the recording. If you have any questions, please reach out to me, @Etienne All the best!

AMA recording: Mike Baca on Quality Leadership

EtienneCommunity Manager

Thank you to everyone who participated in the AMA on Human Factors with Bryant Foster from Research Collective! Great conversation, and I especially want to thank everyone for your patience with the technical difficulties. If you have any questions, please reach out to me, @Etienne All the best!

AMA Recording: Bryant Foster on Human Factors

EtienneCommunity Manager

RoundTable on Clinical Affairs We hope you enjoyed this RoundTable discussion on Clinical Affairs!Let us know what you think - we look forward to more discussion in the future.Thanks,@Etienne Community Manager

RoundTable discussion on Clinical Affairs

asked in Ask Me Anything (AMA) sessions

twhitecentrixNew Participant

IFU - notice to user to report

Annex I, 23.4. Information in the instructions for use(z) a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is establishedIs actual practice and expectation to include a canned statement to this effect in every IFU?

EtienneCommunity Manager

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

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

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

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

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