Medical device consulting as a service: bring your idea for a medical device to market. BAAT (Dutch for ‘benefit’) offers the expertise needed to realize your device, and make it ready for market approval. As a collaborative partner where you keep IP.
Is your development portfolio bigger than your R&D department’s capacity? BAAT has the experience and know-how to transform your dream, idea, technology or problem into a product with manufacturing route, CE/FDA application and operations. Through our streamlined process of medical device consulting and development, we make your product become commercially viable in the market. So you focus on your product while we focus on regulation, testing, CE marking, and advise you on budgets.
During the journey from idea to product there are important topics to address, each with their own flavor of “Medical Device Consulting Inc.”. Do you need medical device design consultancy, or development consulting? Or does your project need medical device regulatory consulting, on a higher level device strategy consulting. First steps are to get an overview of all requirements through reimbursement consultants and medical device quality consulting. Many medical startups find out what they actually need after an innovation scan. Collaborate confidently with a development partner who has it all under control and shows you the way through the woods. Baat Medical is your full-service partner: we’re not just about delivering medical device regulatory consulting services, a drawing or report; we care about creating a meaningful impact on the lives of patients. In the end, that is what we all do it for, right?
Finding the right medical device consultancy path can be a bit challenging. We schedule innovation scans regularly and we’d like to help you get your medical innovation to market. Ready to move forward? Tell us briefly about your idea so we can point you in the right direction.
From idea-to-market medical device to deliver your device to end-users worldwide. This is what we do on a daily basis. With our Development you get all services integrated into a proven system so that you get the confidence to launch and deliver your device within your milestones:
How to turn your idea into a tangible device? Which suppliers to select that best fit your market? We know how to select and qualify medical device suppliers so let’s choose the ones that best fit your device and market. We setup and manage supply chains worldwide and we can do this for you too so you can focus on what drives you most; if that is technology development, sales and marketing or something else. Let’s manufacturing your device and relief you from:
Demonstrating safety and efficacy is critical to your medical device’s success both before and after market approval. We cover all medical device testing areas such as, but not limited to:
Are you looking for an external expert or do you prefer to place an expert consultant in your company? We are here for you. Our experts cover all relevant medical device topics such as, but not limited to:
How to get ISO 13485 complicance? Which regulatory route to take? Which coating to select? And all other questions that you might have related to your medical device. From beginner courses to refresher trainings and customized courses. Your education is our top priority in our trainings solution. Our trainings cover all topics related to medical devices as we provide:
From idea-to-market medical device to deliver your device to end-users worldwide. This is what we do on a daily basis. With our Development you get all services integrated into a proven system so that you get the confidence to launch and deliver your device within your milestones:
How to turn your idea into a tangible device? Which suppliers to select that best fit your market? We know how to select and qualify medical device suppliers so let’s choose the ones that best fit your device and market. We setup and manage supply chains worldwide and we can do this for you too so you can focus on what drives you most; if that is technology development, sales and marketing or something else. Let’s manufacturing your device and relief you from:
Demonstrating safety and efficacy is critical to your medical device’s success both before and after market approval. We cover all medical device testing areas such as, but not limited to:
Are you looking for an external expert or do you prefer to place an expert consultant in your company? We are here for you. Our experts cover all relevant medical device topics such as, but not limited to:
How to get ISO 13485 complicance? Which regulatory route to take? Which coating to select? And all other questions that you might have related to your medical device. From beginner courses to refresher trainings and customized courses. Your education is our top priority in our trainings solution. Our trainings cover all topics related to medical devices as we provide:
Even the most experienced people from top medical device consulting firms are only as good as the quality system they are working under. At least according to the authorities assessing market approval. That means a team of expert consultants is not enough; they must use a thorough quality management system to get regulatory approval for a medical device. Our ISO 13485 quality system concerns topics directly related to product development (e.g. verification and validation, risk management, usability), but also addresses many high-level topics such as competence tracking and training, management of standards, control of documents.
When partnering with BAAT, you will not only benefit from the knowledge and experience of our 25+ team of experts of various fields, but also our underlying quality system. This makes BAAT an excellent partner to completely outsource medical device development versus outsourcing individual topics to specific medical device consulting companies, while still investing in organizing responsibilities and quality management system in house.
When you transform your idea into a medical device you will encounter hurdles. BAAT has created many medical devices for a range of customers since 1999. Use our experience to navigate the intricacies of developing your product and getting it approved for market introduction.
Use our medical device expertise to reach your goals while maintaining flexibility. Contact us today to use our solid foundations of experience, expertise, and our thorough ISO 13485 quality management system.
Paradigm Spine
The way BAAT Medical organizes projects and handles our requests is absolutely great. They have a structured approach that ensures everything runs smoothly and efficiently. One of the standout aspects is their ability to manage topics and make decisions internally, only seeking my input when absolutely necessary. This has not only saved me a tremendous amount of time but also instilled a great deal of confidence in their expertise and professionalism. I highly recommend BAAT Medical to anyone looking for a reliable and proficient partner.
Waldemar Link
The engineering services of Baat really complements our own design process, while seamlessly integrating into our existing operations.
Essity
Thanks to everyone at Baat medical involved in this project. We are very satisfied with your service (including performance, communication, and flexibility) and are looking forward to possible new collaborations.
EIT, a J&J company
Thanks to the close collaboration of our engineers with the BAAT team, we could execute our development strategy as planned. We couldn’t have reached this level of success without them.
Co-Founder & CMO InSpine
BAAT Medical is our reliable R&D partner in various projects. The project with EIT Cellular Titanium®️ medical development has been the cherry on the pie (so far)! Can't wait what next projects are going to bring us.
Belfry Medical GmbH
Successful products are not made only of great ideas; they require a good understanding of today’s and tomorrow’s market environment. The INNOVATE process was very insightful. It helped us define and decide what is necessary to fulfill all stakeholders’ present and future requirements in order to have a high-impact product and treatment. BAAT did a great job!
Business Development
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