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Artificial intelligence and machine learning (AI/ML) are no longer “future trends” in Medtech, they are here, and the FDA is moving...

The global MedTech industry woke up this week to the kind of headline that rattles balance sheets and boardrooms:   The U.S. and China...

While headlines often spotlight India or China in MedTech conversations, a quieter powerhouse has been building strength and focus for decades. During recent conversations at WHX Miami and my annual visit to Malaysia, one insight was clear: Malaysia is no longer just an emerging option, it’s a strategic MedTech hub.

In the competitive realm of Medtech, creativity isn't just an advantage—it's a necessity. From crafting compelling narratives to forging str

Unlocking the secrets to successful Medtech startup fundraising.

Accurately assessing your market size holds a pivotal role in shaping your strategic roadmap and influencing the valuation of your startup

Medical Device File is a term used by ISO 13485, similar but different than a DHF and a Technical File for EU Submission

Welcome back to our blog series focusing on EU MDR compliance strategies. In our previous post, we highlighted the importance of Clinical...

For medical device start-ups, accessing their first market is a pivotal milestone that sets the foundation for future growth and success....

Delving into one crucial aspect of EU MDR compliance: Clinical Evaluation

Conducting a robust market analysis and comprehensive competitive assessment will enhance your valuation as a start-up

Understanding Customer Needs: The Foundation of Successful Medical Device Differentiation

As a medical device start-up, it's critical to assess and segment your market to ensure that you are targeting the right audience with...