Question
Hi All. I was wondering if anyone can point me to documentation that says it is either legal or not to collect a credit card from a patient with insurance or medicaid for a deductible at the time of "purchase" with insurance to cover a remaining bala...
Ayhan Aydin
Account Manager at The Janssen Pharmaceutical Companies of Johnson & Johnson
October 2016
Any advice would be muchly appreciated. How many times are you able to get an extension on the decision regarding TGA submission withdrawals? If you do withdraw your submission, then work to meet the failing criteria, does this mean you will start th...
I rarely make an outright recommendation, but I will today. We get a surprising number of posts about translating materials for medical devices. As the former Director of Marketing Communications for a publicly traded medical device company, I recomm...
Most likely something discussed in the past and hopefully answered easily. We have been completing our 21 CFR Part 820 compliance and are in really good shape for a contract manufacturer of medical devices. I have been receiving competing information...
Acceptance sampling is a technique often used in verification of product. The sampling methods depend on either variables or attributes. Most device companies used published documents such as Z1.4, c=0, or Z1.9. There are other methods, although not ...
Do you any experience working with CROs? I'd be interested to hear from those who have, eg:- What did the CRO(s) seem to do well/not so well?- What kinds of studies did the CRO manage? Feasibility, safety, pivotal, usability?- What was your take-away...
This morning I was listening to my favorite daily podcast. The podcast guest made an extremely controversial statement. He said that he no longer agrees with one of the most popular entrepreneurship books called “Lean Start-up.” The book encourages s...
Hello! I'd like to get some advice from industrial leaders on my inquiry. I am establishing complaint handling process reflecting ISO 13485:2016 requirement and FDA QSR, and one of new step is "Evaluation" for complaints which is many global companie...
Many recently published studies showed that, thanks to telemonitoring, the number of exacerbations, hospitalizations and emergency department visits was reduced by 38 to 58% in COPD patients. Moreover, in case of hospitalization the number of hospita...
Wound Dressing Manufacturers – FDA will be reclassifying your devices. Speak now before October 20, 2016 or forever hold your peace (at least until the proposed rule making)If your company manufacturers wound dressings containing drugs under the FRO ...
