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 des...

Design reviews are critical in the development of medical devices to manage risks, gain compliance, and improve the product before failures that are c...

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

Establishing a clear regulatory strategy is key in medical device project management since it affects time to market, product effectiveness, and cost ...

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

Medtech project managers could argue that managing compliance while pursuing innovation in the design and engineering of medical devices is a delicate...

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 com...

Managing the competing needs of different stakeholders and the market for a medical device is one of the biggest and most important difficulties that ...

I consider that the most complex aspect of managing a project for a medical device is the interplay between challenges in compliance and technology. T...