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 Simbex [...]
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.
