The rapidly-evolving climate of medical device security standards and practices presents challenges for you and your organization. As a medical device manufacturer, understanding your cybersecurity risks and obligations will help
The medical device development process can be long, complicated, and fraught with the potential for error. But many of these potential pitfalls can be avoided, mitigated, or outright eliminated with
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
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