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...
As more and more technology is embedded into products, and software continues its role as the primary driver for product innovation, the domains of application lifecycle management (ALM) and product lifecycle management (PLM) are being placed on an inevitable...
Historically, Product Lifecycle Management (PLM) has its roots in mechanical and electrical engineering, specifically the automotive industry. Its use was pioneered to manage a product (for instance, a car) from inception and on through computer-aided design (CAD),...
Developing new and innovative products is essential for companies to survive and thrive -- however safety can never take a backseat to innovation. That is why many companies, like those in the Medical Devices, Aeronautics and Automotive industries, have strict...
As technology has advanced, it's become more complex -- and with complexity comes the issue of tracking and monitoring the different processes and their corresponding data. In non-critical applications, the extent of this reporting is often minimal. However, in...
As the push towards the cloud continues, the inertia of its popularity can leave CTOs with the impression that the world is black and white with only two options: in the cloud or not in the cloud. The nuances and diversity of solutions can therefore be lost in the...
Choosing and evaluating products for managing data is a daunting task. With the ease of access to broad, general information – which is often conflicting – getting your decision-makers and Very Important People using the same vocabulary is the first step to developing...
