Bill Betten has developed medical devices for decades, but he gained a deeper understanding after hearing a doctor speak the words "brain" and "tumor."
"It's a little different when it's going to be done to you," Betten recalled today during Medical Design & Outsourcing's latest podcast. (Hear more from Betten as editor Chris Newmarker interviews him at DeviceTalks Minnesota, Sept. 9–10 in Minneapolis. Go to minnesota.devicetalks.com and use the code “25OFF” to save 25% on the cost of registration.)
Betten's tumor, fortunately, was a benign meningioma, and he's presently four and a half months into a successful recovery from surgery. Now that he's past the health emergency, there are insights about medical devices that he once knew that he now feels to his core.
Hear more of Betten's insights in MDO's latest podcast, and find out more next week at DeviceTalks Minnesota.
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Bill Betten has developed medical devices for decades, but he gained a deeper understanding after hearing a doctor speak the words "brain" and "tumor."
"It's a little different when it's going to be done to you," Betten recalled today during Medical Design & Outsourcing's latest podcast. (Hear more from Betten as editor Chris Newmarker interviews him at DeviceTalks Minnesota, Sept. 9–10 in Minneapolis. Go to minnesota.devicetalks.com and use the code “25OFF” to save 25% on the cost of registration.)
Betten's tumor, fortunately, was a benign meningioma, and he's presently four and a half months into a successful recovery from surgery. Now that he's past the health emergency, there are insights about medical devices that he once knew that he now feels to his core.
Hear more of Betten's insights in MDO's latest podcast, and find out more next week at DeviceTalks Minnesota.
FDA Form 483s could get easier for medical device companies: Here's how
MedicalDesign&Outsourcing
22 minutes 44 seconds
6 years ago
FDA Form 483s could get easier for medical device companies: Here's how
FDA in the U.S. is in the process of setting up a formal way for medical device companies to get nonbinding feedback about Form 483s, in which agency inspectors raise potential manufacturing process problems.
The proposed process actually standardizes what some in the industry have been doing for a long time: seeking nonbinding feedback from FDA about inspection results and proposed solutions, in the same way a company might hold a presubmission meeting, according to Mike Drues, a Southern California–based regulatory consultant who has worked with both companies and FDA.
Drues discussed the draft guidance during his latest podcast appearance with Medical Design & Outsourcing.
MedicalDesign&Outsourcing
Bill Betten has developed medical devices for decades, but he gained a deeper understanding after hearing a doctor speak the words "brain" and "tumor."
"It's a little different when it's going to be done to you," Betten recalled today during Medical Design & Outsourcing's latest podcast. (Hear more from Betten as editor Chris Newmarker interviews him at DeviceTalks Minnesota, Sept. 9–10 in Minneapolis. Go to minnesota.devicetalks.com and use the code “25OFF” to save 25% on the cost of registration.)
Betten's tumor, fortunately, was a benign meningioma, and he's presently four and a half months into a successful recovery from surgery. Now that he's past the health emergency, there are insights about medical devices that he once knew that he now feels to his core.
Hear more of Betten's insights in MDO's latest podcast, and find out more next week at DeviceTalks Minnesota.
