Design verification is one of the phases in medical device development that serves the purpose of ensuring that the device has achieved all of the design specifications, performance capabilities, and ...

Design reviews are critical in the development of medical devices to manage risks, gain compliance, and improve the product before failures that are costly in nature arise. Medical products are unlike...

Design change requests (DCRs) are bound to happen in the development of a medical device either through user suggestions or feedback, risk analysis, adherence to regulations, or incorporation of new t...

Establishing a clear regulatory strategy is key in medical device project management since it affects time to market, product effectiveness, and cost efficiency. In the absence of a defined route to r...

Each stage of medical device development invariably results in a conflict amongst team members due to the vast areas of expertise required. Engineers, regulatory affairs, quality engineers, marketing ...

Medtech project managers could argue that managing compliance while pursuing innovation in the design and engineering of medical devices is a delicate balancing act. While innovation is an important c...

Focusing on time, cost, and scope during the design and development life cycles of a medical device is one of the challenges of project management commonly known as the ‘Project Management Triangle.’ ...

Managing the competing needs of different stakeholders and the market for a medical device is one of the biggest and most important difficulties that has to be addressed. Investors, regulatory agencie...

I consider that the most complex aspect of managing a project for a medical device is the interplay between challenges in compliance and technology. These two factors tend to reinforce and aggravate e...