Question
Walter Maclay
| President, Electronics, Software Design | Expert Speaker in Wearables, Wireless, Medical Devices, Consumer Products |
February 2019
We are starting to see smart toilets enter the market or get close to entering the market. They include sensors such as electrocardiogram, body temperature, and photoplethysmogram to measure blood oxygen level.What do you think? Is it a medical devic...
Dear All.... Could anyone please let me know the procedure for "how to select and contact a Notified Body?"
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...
There are rumours of potential changes to the FDA approval process particularly geared at devices processed through the 510(k) pathway. Will these changes affect reimbursement strategies?If so, how?
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...
Alison Dennis
Medical Device and Pharmaceuticals Lawyer, Head of Life Sciences Sector Group, Fieldfisher LLP
February 2019
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. ...
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...
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
Danny Kroo
ISO 13485 medical device, AS9100, AS9120 aerospace and ISO 9001 QMS consultant & lead assessor QA/RA Manager at Montmed
January 2019
A company is interested in getting a private label agreement with an OEM to sell a Class II medical device in the USA. The OEM has 510(k) clearance and the only product change will be the company's name on the label. There will be no change for the i...
I'm really hoping this message gets out to anyone planning a clinical trial, so please forward it to your network. This is an ambitious post, sharing two great 10x Conference presentations.Doug Fankell, Ph.D. (on left) is an engineer with Structural ...
