Question
Someone told me that it's possible for a med device company to use their contract manufacturer's ENTIRE quality system as their own. He said since design and development is outsourced, his company could just use all of the manufacturer's procedures a...
Dean Harper
Driving the business forward through culture change, Lean Six Sigma tools and techniques.
July 2015
Does anyone know if there are any hard and fast rules around validation of a filling line used for dispensing medical diagnostic reagents. For example how many bottles should you test during PQ if your typical batch size is to be 5000?source: https:/...
Is the biomedical engineering technician community still striving to become a recognized profession?
Several years ago, there was a great push from the biomed community to become a profession. What is the status on that pursuit now?source: https://www.linkedin.com/groups/78665/78665-6023992469094412289
My neighbors son has Duchenne muscular dystrophy. He was diagnosed at the age of 4 and at the time his father could not find a scooter that his son could use. So he designed and built a scooter that helps him get around and more importantly helps him...
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This is an amazing application of 3D printing technology. I would really like one of these hearts for research! It would also make a great courtroom exhibit or teaching aid.First 3-D heart printed using multiple imaging techniquesCongenital heart exp...
Relax pre-market to speed introduction, and increase post-market to ensure patient welfare. Makes sense to me. Is the FDA Too Tough on Medical Device Makers?Are the FDA's medical device regulations too hard, too soft, or just right? Wharton research ...
Here's a recap of some things you may have missed over the past few months. First, Rhonda Rhyne's keynote speech from this year's 10x conference. You can watch it at http://medgroup.biz/Rhyne-keynote After an interesting presentation about the power ...
I have a question regarding used/refurbished devices, Does anyone know which countries are allow to sell them? and the regulations? source: https://www.linkedin.com/groups/78665/78665-6017094814523285506
I'm writing you from Southern Australia. You may recall my friend, Technologist Greg Eaton http://bit.ly/Greg_Eaton, invited me to mentor startups at incubator http://medgroup.biz/innovyz for the week. Yesterday Greg shared a May 29 Brisbane newspape...
