Question
source: https://www.linkedin.com/groups/2070960/2070960-6065525571830505474
Risk management is one of the hottest (and at times, most confusing) topics in the medical device industry today. ISO 14971, the current risk management standard for med devices, provides a thorough explanation of relevant terms and defines the risk ...
While market research firms are drafting their predictions of what medical device trends to expect for next year, I thought it would be an interesting time to get some feedback from medical device professionals directly. I'll share a few things I've ...
I sat through a terrible pitch last week. Too bad he didn't watch this 10x video first: http://medgroup.biz/med-device-pitch Crystal Research's Jeffrey Kraws' comments stuck with me. He said, "Assume I already know this: • I already know you’re going...
CFO Rick Baron (Zynerba Pharmaceuticals, Globus Medical) gave us his perspective on being a chief financial officer in the life science industry at the 2015 10x Medical Device Conference. Click here to download the transcript.
The most common nonconformity identified by reviewers of a CE Marking submission is an inadequate or missing clinical evaluation report (CER). Preparing a CER is time consuming, but if you have a good protocol and procedure the process does not need ...
Oh, boy. Methods of treating patients. So many issues. Many countries exclude methods of treatment from patent eligibility. They believe it is unethical to restrict treatment of a patient. They probably have a point. However, this must be balanced ag...
In addition to inhouse production and OEM outsourcing, there are always items that make more sense to just purchase and sell as 3rd party items to convenience customers.When should 3rd party items be regulated according to a Quality Management System...
Some organizations view regulatory and technical standards compliance as a goal to be achieved. Others simply a real pain-in-the-butt to accomplish. While I will be the first to agree that some of the seemingly excessive documentation requirements in...
CAPA-Corrective and preventive Action...Every day a seminar on CAPA is being held somewhere, it’s one of the simplest, but most misunderstood process we deal with every day!Many companies have not only their "formal" CAPA process, but also have sever...
