Question
This will be a great questions for FDA and folks who work in Medical Device Industry:I was browsing on some free images about medical devices because I'm currently writing a book. It occurred to me to post something in the Medical Device Industry com...
Justyna-Wanda Niewiadomski, MBA
Director Group R&D Quality & Clinical Affairs Management bei Sonova Gruppe bei Sonova Gruppe
May 2016
To get an CE Mark for a device which needs to go to a clinical study and do not have any results to proof the safety and performance requirements. Is there a similar process/procedure in Europe like in Us for the IDE (Investigational Device Exemption...
Has anyone got any experience of working with the TGA? I sent in a Devices query at the end of March and received an automated response saying they would respond in 5-20 days. So far, nothing.source: https://www.linkedin.com/groups/78665/78665-613543...
In late 2014 and the beginning of 2015 I wrote a three-part series of blogs about controlling nonconforming product. The blogs explained the three steps for controlling nonconforming product: 1) identify and segregate, 2) disposition of nonconforming...
Innovative university developed technologies seeking industry collaboration could be the answer to bringing down the 1.5 million death toll due to diabetes. Read more at: https://blog.in-part.com/revolutionising-life-for-diabetics/source: https://ww...
Thomas Jull
Medical device operations management - R&D | Manufacturing | Market Service & Support
May 2016
Katie Weimer's presentation on, “3D Printed Medical Devices: What’s Next?”, at the 10x Medical Device Conference was amazing. Some great examples of how the technology is being used to form ‘patient-specific’ replacement bone sections, and scope for ...
At MDMS, the Medical Device Marketing and Sales Workshop, last February, Utah-based Nic Anderson from Intermountain Healthcare made such a great point I asked him to write today’s post. He writes, Payers go to conferences, symposia, lectures and read...
I have been working for over a year now bringing a new product to market designed for people with mobility issues, specifically the elderly. With 80% of falls happening in the bedroom between the hours of 9pm-6am, getting in-and-out of bed is a big c...
Interesting read from a general surgeon. "Government interventions over the past four decades have yielded a cascade of perverse incentives, bureaucratic diktats, and economic pressures that together are forcing doctors to sacrifice their independent...
Hello All: In ISO 14971 Medical Devices--Application of Risk Management to Medical Devices clause 4.3 is "Identification of Hazards." It requires the manufacturer to compile documentation of known and foreseeable hazards associated with the medical d...
