All medical devices sold must adhere to medical device labeling standards set forth by the FDA and other regulatory bodies. Labeling is provided for the end-user to consult, as well
With over 250,000 annual deaths reportedly caused by medical error, human factors and usability testing has become an increasingly scrutinized step in medical device design, development, and manufacturing. The word
The term “medical device”, as defined by the U.S. Food and Drug Administration (FDA) covers a broad spectrum of objects. Tongue depressors, gauze pads, and surgical masks all qualify as
Medical devices can be lifesavers, both for immediate issues (such as defibrillators for heart attacks) and long-term care (such as pacemakers). However, without adequate testing, medical devices will deliver subpar
In our post, You Can Realize a Competitive Advantage Through Outsourcing, we discussed how product development can and does provide a competitive advantage. The main point said competitive advantage is
When a company contemplates improving their competitive position in the marketplace, they typically think about doing something internal to transform their posture—like mastering a new technology, developing an innovative process,
The RoHS Recast Directive for manufacturers and importers became law on January 3rd, 2013 and medical devices will also need to be compliant with the regulatory requirements starting in July
Most organizations outsource some or all of their product development projects to a medical device development company because they limit their internal capabilities to focus on success or because they’re