Question
last month
Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
As originally asked by Suresh Kumar Muniandy. Dear members, I have a question on the MDR labelling requirements -UDI. Is there any exemption on placing serialization numbers on UDI labels if your product is manufactured in bulk and is at class IIb (n...
last month
Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
As originally asked by Philippe Coriat. Does anyone have any idea about the cost of rapid prototyping for an orthopedic implant? (knee) Charline Chen Plant Manager - Magnet Marrili Automotive lighting (XG)Ltd show me your idea please, we can use 5-X ...
last month
Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Many start-ups and early-stage biotech companies have this dilemma. Build or borrow?If I build - big expense, but more security for my IP.Contract and risk my tech escaping into the wild.
February 2019
Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Every medical device promises "Improved Patient Outcomes." That is, except commodities and less expensive devices claiming parity with the incumbent solutions. Buried under 8 inches of snow – they consider this a State of Emergency in Seattle – and t...
February 2019
Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Guess how many software deployments Amazon did each day in 2012. Approximately 23,000. Of course, that's Amazon. You don't need anywhere near that many. But your slow, painful software development process leads to poor software quality, said embedded...
February 2019
Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Please forgive the decidedly American question. To make it interesting, I'll give free 10x Conference admission (http://medgroup.biz/10x) to the first Medical Devices Group member who guesses the correct teams and score of this year's Super Bowl. No ...
February 2019
Alison Dennis
Medical Device and Pharmaceuticals Lawyer, Head of Life Sciences Sector Group, Fieldfisher LLP
The UK is heading ever closer to the precipice of a "no deal" Brexit. It is now less than two months until the UK is due to exit the EU on 29th March and no agreement acceptable to the UK parliament has been reached on how that exit will be managed. ...
January 2019
Ritika Tyagi
Vaccines & Medical Professional at MarketsandMarkets
Nasal sprays cause complications including nasal mucosa irritation, dryness, temporary burning, and runny noses.This is because nasal sprays have a chemical to shrink blood vessels. Thus, continuous use may render the vessels to be less responsive to...
January 2019
Joel Hale
Director of Clinical Affairs
Any recommendations for a great CRO with ENT device experience who understand the unique challenges associated with a small surgical device company? Would prefer they have their own EDC system and also work in Germany. Thanks in advance, Joel
January 2019
Gregory Dingas
COO at Gr Dinga Sons SA
I seek a cleanroom facility (full body suit) that is sterile individually packed / triple-pack in sterile Pasteur pipettes (1-2 ml) and ship in a Cryovial. The drug is manufactured for a major multi-national firm. Who can you recommend, thank you?