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...
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 ...
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.
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...
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...
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 ...
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. ...
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...
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
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?