SPK and Associates co-founder Chris McHale previously spoke with PLM expert Oleg Shilovitsky, founder of BeyondPLM.com, to get his top three product lifecycle management (PLM) predictions for 2015. Now they are teaming up monthly to discuss relevant industry items...
In the world of fast competitive marketing, a lot of attention goes to the first company who develops a creative breakthrough and comes out with a cool new device first. New technology in the medical device market has resulted in several new products which include;...
There are so many tools that are available to help make the process of coding more efficient, less time consuming, and overall a better experience. There are a number of tools / configuration settings I utilize in my environment to help make my overall coding /...
Put it in the cloud. You’ve heard this catch phrase over and over again, more so in recent years with the proliferation of online technologies and services. As more and more PLM software vendors choose to move their application to the cloud, should you consider moving...
Greater medical device interoperability and the adoption of commonly accepted standards could save the US in excess of $30B, suggests a West Health Institute report published in March. Lack of device interoperability creates significant waste and risk to patient...
Product lifecycle management (PLM) systems have evolved from being custom-built, on-premise applications to cloud-based, off-the-shelf solutions. As adoption for PLM in the cloud increases, system validation approaches in FDA/GXP regulated industries have had to...
As of July 22, 2014, the RoHS (Restriction of Hazardous Substances) Directive must be observed for first time distribution of all medical devices to the full extent. Furthermore, all products with a CE marking must also be RoHS-compliant. ROHS 2 Compliance Changes at...
Medical Device manufacturers regulated by the FDA are subject to cGMP (Current Good Manufacturing Practice) regulations and may be inspected by the FDA to ensure compliance. If the FDA inspector(s) observes conditions that in their judgment may constitute violations,...
A critical business challenge for medical device manufacturers as they scale is getting products to market quickly while supporting existing products and meeting FDA Quality System Regulation (21-CFR-820) requirements. To achieve this effectively, Product Development...