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I begin this conversation with a question: Which factor have you found to be most important in terms of setting a purchase price for a successful market launch: Hospital bundling, a desire on the part of the surgical/medical staff for the device, or ...

I am trying to break into the Medical Device Sales Industry after 20 successful years as a Spine Physician.Due to changes in insurance reimbursement and driven by a new passion for surgical Health Care, I closed my clinic, moved 4 hours away from my ...

A single-member LLC with a non-US alien owner wants to sell Class I, 510(k)-exempt medical device via Amazon FBA. The manufacturer of the device is a foreign business entity and has a valid FDA registration. The LLC wants to sell the medical device a...

Is there any specific time line to update the labels including the UDI/human readable requirements for the *Class* *I* and *Ir* devices.

I frustrated regulatory expert Michelle Lott because, despite us having discussed it many times, I still couldn't grasp how draft documentation can screw up FDA submissions. Bless her Southern heart, she persevered. We recorded the call and you can u...

God bless Michael Seres. He was diagnosed with Crohn’s disease, an incurable bowel condition, at age 12. His first surgery at 14, he's 25 further surgeries stronger, having weathered intestinal failure and two bouts of cancer. He's now awaiting a ste...

I get asked the same questions all the time. "Joe, I am looking for a new position and/or I'm looking for new clients for my consultancy. Do you know of any opportunities for me?" "Joe, I am looking for sales representatives (1099) and/or distributor...

I stumbled upon a significant idea with regulatory and quality expert Michelle Lott last week. Seize it immediately! Here's that 9-minute conversation. Get or renew your CE mark TODAY! If you prefer reading, the conversation highlights are: Get or re...