R&D

Risk management is a crucial aspect of medical device development. You need to account for and mitigate the risks associated with your product early on, so it’s safe for users and passes [...]

It’s a consequential decision to hand over the responsibility of designing your medical device to an outside team — even if it’s only for part of the project. You need to have a lot of trust and [...]

Of course, you’ve been feeling the landscape shift for years. That’s why you’re already so concerned about time to market and first mover advantage. The problem is that your medical device [...]

Creating a comprehensive traceability matrix hinges on sourcing accurate user, safety, science, and technology needs related to your medical device. Like most companies, your firm is probably [...]

New medical devices offer fresh opportunities for your company to improve health outcomes, push the boundaries of medical innovation, and grow your business. Who wouldn’t be excited about that? [...]

The FDA requires user interface specifications for medical devices. But your user interface specification can and should be more than a requirement or regulatory box to check.