Most organizations outsource some or all of their product development projects to a medical device design and development company because they limit their internal capabilities to focus on success or
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 development stage is one of the most significant steps in the entire manufacturing process. During this stage, engineers and designers can work out any errors, inconsistencies, or failures in
The term medical device covers a wide range of devices. Adhesive bandages, surgical masks, and tongue depressors are all medical devices, as are room-sized magnetic resonance imaging (MRI) machines. Even certain computer
Medical devices undergo rigorous testing and evaluation before they are allowed to be marketed and sold. But did you know that the design of medical device packaging can be just
In 2013, the U.S. Food and Drug Administration (FDA) learned that high rates of postoperative infections were observed among patients who had undergone endoscopic retrograde cholangiopancreatography (ECRP). In this procedure,
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