BAAT Medical Articles

15 Articles

Clinical Investigation - Roles & Responsibilities
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Clinical Investigation; Roles & Responsibilities

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

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FDA 21 cfr 820 stamp approved
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FDA 510(k) Pathway and Opportunities Introduction

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

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what is biocompatibility testing for medical devices
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Biocompatibility Testing for Medical Devices

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

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Surgical Trial Implants, what is a clinical evaluation? Introductionary whitepaper to clinical trials for medical devices
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Medical Device Development and Clinical Evaluation Introductionary Whitepaper to Clinical Trials and Investigation BAAT Medical

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

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Unlocking Success in Orthopedic Medical Device Startups by BAAT Medical Products
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Unlocking Success in Orthopedic Medical Device Startups: A Guide to Profitable Exits

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

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FDA versus MDR for classification of medical devices by BAAT Medical Products
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FDA Versus MDR for Classification of Medical Devices

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

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Key Strategies for Developing a Successful Orthopedic Medical Device Startup
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Key Strategies for Developing a Successful Orthopedic Medical Device Startup

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

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Harnessing Orthosis Development, Innovation, and Product Improvement
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Harnessing Orthosis Development, Innovation, and Product Improvement

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

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Why is CE Marking Required for Medical Devices?
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What is CE Marking Required for Medical Devices?

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

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cost of medical consulting - medical devices ce mark outsouring
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The Cost of Developing a Medical Device: Insights from Medical Consulting and CE Mark

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

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Private: Engineering an Implant – Lessons Learned from Gannet and Arthrosave

Lessons learned from MedTech company Baat Medical: Small print matters Why we write on this topic “November 2 is ...

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Tips for Medical Device Startups
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Tips for Medical Device Startups

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

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Mondkapje - (FFP) Mondmasker - Fabrikanten
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Mondkapje – (FFP) Mondmasker – Fabrikanten

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

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Regulatory Aspects of 3D-Printed Surgical Implants
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Regulatory Aspects of 3D-Printed Surgical Implants

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

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Innovations
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Innovations

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

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