Question
Hi I have been reading about UDI and the changes in the tobacco laws and industry.What are your views on the topic of e cigarettes will they be classed as a medical device?I keen to hear thoughts.source: https://www.linkedin.com/groups/78665/78665-62...
source: https://www.linkedin.com/groups/78665/78665-6211618860588761089
I would be very interested in feedback on positive or negative experiences of group members with rapid prototyping/lean startup principles in medtech startups, and even in the introduction of new products by more established organizations. To what ex...
According to Article 13 of the new medical device Regulation entitled “Person responsible for regulatory compliance” , “manufacturers must have available within their organization at least one person responsible for regulatory compliance who possess...
As originally asked by Christopher O'Connor Steve Maylish I always contact Andy D'Esposito at Merrill's Packaging: andy@merrills.co.com Joe Hage I love when group members help one another. Thank you, Steve. Terry Dowe Christopher give us a call at 80...
Group member Richard Bayney writes, "Everyone likes a portfolio of prioritized projects but how do you know that this portfolio creates the highest value for your company? Unfortunately, if you don’t search for the highest value portfolio, you’ll nev...
Frequently I am asked if minor device modifications, such as a color change, requires a new 510k submission. In general the answer is typically yes, and this surprises most manufacturers. In order to help make this decision, the FDA released a new dr...
Is this going to be solved exclusively with pharmacology or might devices play a role? 3 preparation tips to head off 'explosive' Zika pandemic - FierceHealthcare http://ow.ly/XEl9w Brian Marckx, CFA Director of Research. Senior Equity Research Analy...
Prolific group contributor Paul Stein was recently at a scientific society conference that had a session on entrepreneurship for scientists and engineers. The moderator asked the three speakers what their budding companies' exit strategies were. Each...
As per process validation definition in ISO-13485 and FDA CFR 21 Part 820 I have a concern where help from groups members is really appreciated,Recently I read a procedure that states that, since regular lots size are too big, sampling can be conduct...
