FDA medical device regulations govern the manufacturing of medical devices. Medical device FDA regulation requires manufacturers to comply with all necessary principles before they are approved for sale. According to
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
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 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