Commercialization

Medical device regulatory and reimbursement strategies in the US have often been considered two separate activities, dealing with two separate stakeholders that, to some, are not in sync with [...]

  Adopting new healthcare technology is never easy, especially when it involves reshaping how clinicians interact with patients outside the clinic. In this on-demand webinar, experts from [...]

Thinking About Reshoring Your Medical Device Manufacturing? Here’s What to Know. At Simbex, we’re seeing more and more medtech innovators explore reshoring—bringing manufacturing back to [...]

  Navigating the complexities of AI technology can be daunting, especially when it comes to the development and launch of AI medical devices. In this insightful on-demand webinar, a [...]

As the wearable tech industry continues to blur the lines between consumer and medical devices, it is critical to understand the top considerations for developing innovative, compliant, and [...]

  As an early-stage medical device company, balancing quality assurance, regulatory compliance, and customer feedback can feel overwhelming. That’s where Simbex and Cognidox come in to offer [...]

Regulatory bodies around the world mandate that medical device companies adopt a “risk-based approach” to their design and manufacturing activities, citing ISO 14971:2019 as the gold standard.

The U.S. health innovation landscape is among the largest globally, making it an attractive target for international companies. However, navigating this landscape can be complex and confusing to [...]

Regulatory FDA finalizes guidance on how clinical decision support software is regulated FDA has published final guidance on determining whether clinical decision support software is considered a [...]