Fewer resources and more requirements are hindering the process.
There’s no excuse. FDA really does make it easy.
This year’s COMPAMED trade fair will serve as a catalyst for more industry partnerships.
What is the responsibility of the design owner? What level of accountability does the supplier have? What follow-up actions must a supplier take? A variety of best practices need to be driven forward by both suppliers and OEMs in an organized manner to ensure patient safety.
REACH, which stands for the Regulation, Evaluation, Authorization and Restriction of Chemicals, is a standard that was established by the European Union (EU) in 2007 but does not go into effect until 2018. Simply put, REACH immediately seeks to “limit or prohibit the use of toxic substances in products.” According to an article written by…
Requiring clear supplier agreements can force some tough conversations. Acme Monaco’s Lucas Karabin, and Hogan Lovells attorney Jodi Scott, discuss the importance for such agreements, and what they should ideally cover.
“If you are doing a wound care dressing, what is unique about the product, what are you doing differently than what is already in the market, what is it intended to be used for, who is using it, and where is it being used… All of these pieces of information help you decide how to proceed.” – Jeff Kaminski , President of MBK Tape Solutions. Excerpts from an interview.
One concern we frequently hear is absorbing the expense associated with training and then key employees departing the organization for greener pastures after their training has been completed. But what about the costs associated with mistakes and errors employees make, when employees are not properly trained and decide to stick around?