Many device manufacturers struggle to stay current with FDA thinking on controlling the quality of both their product and the development process. Design Control is defined by the FDA as a basic requirement for medical devices in 21 CFR 820.30(a)(1): Each manufacturer of any class III or class II device, and the class I devices [...]
Posted on 22. Aug, 2016 by Karl Kapp.
If you are finding that your eLearning module or your classroom instruction isn’t eliciting the desired results, it might be that you failed to conduct an adequate needs assessment. A needs assessment is simply a technique or series of techniques designed to identify the root of a problem. For example, if employees are not in [...]
FDA regulations and guidance are becoming increasingly specific for identification of marketed medical devices. These requirements are intended to facilitate the accurate reporting of any adverse events, and coordinate device recall and/or required replacement for patients, physicians, distributors and manufacturers. These regulatory updates from the FDA include clarifications on Unique Device Identifiers (UDI) requiring precise, [...]
While MedSun is not new, many organizations still do not know all about the details behind it. However, they could benefit tremendously from some more detailed knowledge about MedSun. MedSun is short for The Medical Product Safety Network. MedSun is an adverse event reporting program launched in 2002 by the U.S. Food and Drug Administration’s [...]
Over the past few years, FDA has made available a number of documents to help manufacturers determine how to report post-approval changes in chemistry, manufacturing, and controls (CMC) of their products. Specifically, FDA’s Scale-up and Post-Approval Changes (SUPAC) guidance has been aimed at specific dosage forms. SUPAC documents provide “road maps” for making regulatory decisions [...]
Posted on 08. Aug, 2016 by Karl Kapp.
A complaint of many doctors is that their time with patients is greatly limited by their requirement to take technological notes; in fact, I have a physician friend who absolutely refuses to use the electronic medical note taking and prefers to take notes by hand. Well, it turns out that having a physician handwritten notes [...]
As more Life Sciences companies add images to their policies and procedures, it only makes sense that these same images should be applied in related assessments. Clients add images to their SOPs to improve adherence to the procedures and work instructions. And studies have confirmed that the use of “illustrated text” improves retention, as opposed [...]
Posted on 01. Aug, 2016 by Karl Kapp.
With the widespread advent of the Zika virus, the FDA is redoubling its efforts to help come up with a solution. The Zika virus was discovered in Uganda in 1947. It is a member of the flavivirus family. Other flaviviruses include dengue, yellow fever, and West Nile. Like its relatives, Zika virus is primarily transmitted [...]
Posted on 27. Jul, 2016 by Rob Sims.
Just as ISO 9001:2015 emphasized the risk management model, shifting from the classical CAPA approach, so too does the updated ISO 13485:2016 for medical device manufacturers. Fortunately, before the standard was updated in early April, many of our medical device clients had leveraged the ISO 14971 standard to implement risk management systems throughout the entire [...]