Question
Group member Samer took advantage of the question box at http://medgroup.biz/advisors and asked our resident Medical Device Sales Expert Mike Sperduti a question. He wrote, "We manufacture sutures in Turkey. How to reach new clients, distributors, ag...
I am interested in learning the best process for acquiring an ISO 13485 Certification. From the research I have, it seems like accredited 3rd parties are the best way to go. However, there does not seem to be much information about the process as a w...
I recently reviewed a sterilization validation protocol for a client and I thought some of you might be interested in the things that needed to be modified:1. Make sure you specify the revision of all standards referenced and make sure the version is...
As originally asked by Bob Leech. (obviously a lot of factors go into this like sales cycle, training etc - just trying to get a straw poll) Erik Kulstad Associate Professor, Emergency Medicine, UT Southwestern ‖ Co-Founder Attune Medical Having rece...
Question: What is the Acceptable failure rate of sterility in sterile disposable products?. Let's say that a production batch of 1 000 000 sterile disposable syringes is produced, sterilized, shipped, distributed, sold, shipped, and the sterile pouch...
A group member told me a patient-led class action lawsuit against Theranos is making an already skittish medtech investment community even less likely to fund medtech innovation. "I've never heard of an investor getting sued for a portfolio company's...
source: https://www.linkedin.com/groups/78665/78665-6196217829096771589
Kind of an odd article. The interesting part might be what is left unsaid.University offices of technology transfer do their best to license out their technologies. If they can't find a licensee, they are not in the business of marketing the product,...
Hi all,I was wondering what exactly a Qualified Person (QP) in the field of medical devices does and means? According to some sources which I am reading, it says “Manufacturers shall have available within their organization at least one qualified per...
From the utilization of oral anti-inflammatory drugs too invasive surgery, medicine historically treat the symptom of musculoskeletal pain rather than try to identify cyclic load conditions that are causing the symptoms. Analysis of cyclical conditio...
