BAAT Medical Articles

Since the introduction of the Medical Device Regulation (MDR) in Europe, quality management systems (QMS) and regulatory compliance have ...

The landscape of medical device regulation in the European Union (EU) has undergone significant changes with the implementation of ...

When developing a Medical Device, pre-clinical testing is critical to quantify & qualify the performance of your product. BAAT ...

Assuming that simply following a development process stage by stage will lead to success in MedTech product development is ...

In the European Union (EU), in general, medical devices must undergo a conformity assessment by a notified body. This ...

The US is becoming a priority market for medical device development more than ever before. And most of current ...

Biocompatibility testing, more than choosing the right materials “My device consist only of titanium, stainless steel or PEEK, and ...

In the European Union (EU), in general, medical devices must undergo a conformity assessment by a notified body. This ...

In this guide, we will explore the optimal approach for developing a successful startup in the medical device and ...

Medical devices appeal to the imagination and many entrepreneurs want to raise money in order to translate their great ...

Discover the best approach to develop a startup in the orthopedic medical device industry and achieve a profitable exit ...

Often, we hear that an orthosis is fully developed. There are no significant innovation and the improvements that are ...

Understanding the significance of CE marking for medical devices is crucial when marketing these products within the European Union ...

Understanding Medical Device Development Developing a medical device involves a complex and highly regulated process. It requires expertise in ...

Medical Device Startups come to BAAT Medical Author: Ortho Spine News and Elizabeth Hofheinz, M.P.H., M.Ed. In today’s tight ...

Ik kan mondkapjes en/of mondmaskers maken, wat nu? Een praktisch stappenplan voor nieuwe fabrikanten Introductie Er is door de ...

A very interesting article was recently published which highlights the regulatory aspects of custom made 3D-printed surgical implants. Challenges ...

Not all innovations make it to market. There is even a Museum of Failure that shows a multitude of ...