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Medtech Snapshot: Compliance Debate featuring Stephanie Rallis-Daw & Robert Lahaderne

10/11/2023

 
We're breaking the mold!

Medtech Snapshot returns with an enticing debate as #RAQA medtech industry experts Stephanie Rallis-Daw, RAC, CQE, CMDA and Robert Lahaderne, MBA spar on the topic of "When starting a new job/ project, what is the most common medtech compliance shortfall you can expect to encounter at your new company?"

New to Medtech Snapshot? Check out our archive of past episodes at https://www.sqr1services.com/white-papers/category/snapshot covering topics in R&D, Quality, Clinical and Manufacturing. Honey for your eyes and ears, friends.

#medtech #snapshot #podcast #medicaldevice #compliance #quality #regulatory #documentation #training
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Medtech Snapshot - Maximizing Operational Effectiveness with COO, Todd Abraham

9/19/2023

 
In this Medtech Snapshot episode we cover strategies for supplier management and maximizing operational efficiencies when it comes to getting work done. Listen in as Todd Abraham, medical device chief operating officer, explores creative outsourcing, commodity-based decision making and practical manufacturing operation considerations.

Need help making a decision on which tasks to keep internally versus to consider outsourcing?

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Medtech Snapshot: Cybersecurity Regulation in Devices

8/15/2023

 
In this week's #medtech #snapshot we're joined by Michelle Caulfield, VP Global Quality, as we talk about medical device data protection and regulatory standards from a cybersecurity perspective. Hear about the considerations for the October 2023 deadline for section 524B, Ensuring Cybersecurity of Devices.

Check out our library of Medtech Snapshot episodes at https://lnkd.in/gFwF9GYN

Want to learn more about FD&C Act section 524B, go to: https://lnkd.in/gDeumUcb

#cybersecurity #medicaldevice #qualityassurance #qualitycontrol
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Medtech Snapshot: Medical Device Startup Management Success Requirements

8/8/2023

 
What does it really take?

Today's episode of Medtech Snapshot features our managing director Travis N. Smith as he covers the outcome of an online survey we hosted to learn what people thought 'is the most important characteristic a medical device start-up management team needs in order to successfully take a product to market'. So, the question remains - what does it really take for a management team to bring their product to market? Listen in and find out!

If you're enjoying our Medtech Snapshot 3-minute digests be sure to check out our other episodes at https://www.sqr1services.com/white-papers/category/snapshot
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Avoiding Medical Device Project Scope Creep

8/3/2023

 
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​The world around us is ever-changing and constantly evolving, and for those of us who are leading teams, projects or companies this presents a daily challenge.  One area in the business world where we commonly run into change, or scope creep as many of us like to call, is in project work. It doesn’t matter if you are running an internal project, or if you are a consultant operating externally, change in work and projects alike seems constant.  If you are new to the term, scope creep is defined as “changes, continuous or uncontrolled growth, in a project’s requirements, at any point after the project begins.”  Simply put, it’s a change in plans that was unplanned for after the starting point of a body of work.​

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    About the Author

    Travis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services.  He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA.

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