Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?
Superbugs.
Reprocessing.
The White House.
And Design Controls.
Probably not a combo of topics you see grouped together very often.
But we have them all for you on today’s Global Medical Device Podcast.
This is the 2nd edition in our series focused on Design Controls and related topics within…
Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers
Are you a medical provider or caregiver unable to find facemasks as PPE for COVID-19? Get one for free.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Sanjay Vakil and Devon Campbell from MasksOn.org to discuss the impactful efforts being made through the MasksOn initiat…
How Being Strategic During A Career Transition Can Yield The Best Opportunities
There is a spectrum of feelings someone may experience in the midst of a career transition. For some, however, being laid off can turn out to be one of the best things to ever happen to them.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Aaron Moncur, owner of Pipeline D…
Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry
Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself? There’s a supplier management solution that will make your job a whole lot easier.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-owner of QUNIQUE,…
What "Exempt" Means with Respect to Medical Devices & Regulatory
How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a device is classed?
This is the focus of today’s episode with recurring guest Mike Drues, in a conversation with host Jon Speer, found…
Pros & Cons of Being a Physician turned MedTech Inventor
Do you fear needles and the associated pain? No one understands this fear more than physicians who see it firsthand with their patients day in and day out. And one physician in particular set out to do something about it.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Dr. …
How Mindset Training Can Help Your Team Operate at Peak Performance
Close your eyes, take a deep breath in, and imagine your team operating at peak performance, exceeding goals and each member feeling and working at their best. Now, breathe out, letting out a sigh of relief knowing that's fully within the realm of possibility — through mindset training.
In this epi…
What is a Multiple Function Device?
What is a multiple function device? From a high level, it’s a product with at least one portion that meets FDA’s Code of Regulations’ (CFR) definition of a medical device and at least one other portion that does not. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drue…
Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead
If you love learning and want to level up your medical device industry knowledge on topics such as audits, document management, design controls, risk management, and more, Greenlight Guru Academy is your education destination.
In this episode of the Global Medical Device Podcast, Jon Speer invites …
Project Management for Product Development of Medical Devices
What is the best way to approach project management (PM) for medical device product development? Don't settle for the trial and error method, turn to the experts with proven best practices for managing your product development project.
In this episode of the Global Medical Device Podcast, Jon Speer…
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