Medical device consulting as a service: bring your idea for a medical device to market. BAAT (Dutch for ‘benefit’) offeres 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.
In order for you to understand the supply chain needs, you’ll want to get curious about the complicated puzzle that is medical manufacturing. Get to control, trace and monitor all aspects you will encounter from production, packaging, sterilizing, storing, transport and inspection by outsourcing your supply chain and leveraging our network of trusted and verified suppliers. We let you be the master of logistics and supply and ensure all control and safety in the medical supply network.
Contact us todayOur competent BAAT team will develop your product and manufacturing process and provide all documentation needed to get market approval. We have learned that development of a medical device is a dynamic process, that never follows a straight line from start to finish. We will provide you with the right input to decide on next steps in the process. This allows us to achieve the best results possible within the time and budget restrictions you have set.
Contact us todayEnsuring Clinical Safety and Performance is paramount when developing and marketing a medical device, especially for the European market. We concentrate all our activities around one question: Does the expected benefit of your device, when following the intended use, outweigh the inherent risks? Our Clinical Specialists know how to answer this question in the most efficient way. They navigate this delicate process, define the optimal route for collection of Clinical Data to get market approval and to access clinical safety and performance throughout the complete lifecycle of your product.
Contact us todayTo bring your innovation to the market include various legal liability issues, associated with being a (legal) ‘manufacturer’ as is directed by the MDR and FDA regulations. This has nothing to do with intellectual property, branding or ownership; it is the formal legal responsibility, that is directly linked with the entity that develops, manufactures and delivers a medical device for use to the market. At BAAT we know what it means to bear this responsibility because we are able to formally act as legal manufacturer on behalf of our customers. We can help you to identify and solve liability issues throughout the manufacturing chain, put the right insurance coverage in place and make sure that all quality agreements are properly connected.
Contact us todayTo ensure a successful collaboration, we strive to understand your goals and business opportunities and get clear how our services fit best in your journey. With our 20+ years of experience we understand the dynamics of getting an idea to the medical device market. We will help you formulate the right strategy for device development, manufacturing, regulatory affairs, safety questions, clinical trials and legal obligations to get your medical device approved in the EU and US. Together we define and refine the crucial steps to reach your milestones.
Contact us todayYou probably know that regulatory affairs is an important piece of your medical devices puzzle. Which rules apply for your project in order to get approval from FDA and MDR? You want to be fully covered and know about existing and upcoming changes in regulations. Be smart and do not go reinventing the wheel. Instead make use of our proved ISO 13485 certified Quality Management System. This system is specially built to assure compliance from approval throughout the complete lifecycle of your product. We designed our QMS to ensure a fluent transfer and be linked to you own processes easily.
Contact us todayIn order for you to understand the supply chain needs, you’ll want to get curious about the complicated puzzle that is medical manufacturing. Get to control, trace and monitor all aspects you will encounter from production, packaging, sterilizing, storing, transport and inspection by outsourcing your supply chain and leveraging our network of trusted and verified suppliers. We let you be the master of logistics and supply and ensure all control and safety in the medical supply network.
Contact us todayOur competent BAAT team will develop your product and manufacturing process and provide all documentation needed to get market approval. We have learned that development of a medical device is a dynamic process, that never follows a straight line from start to finish. We will provide you with the right input to decide on next steps in the process. This allows us to achieve the best results possible within the time and budget restrictions you have set.
Contact us todayEnsuring Clinical Safety and Performance is paramount when developing and marketing a medical device, especially for the European market. We concentrate all our activities around one question: Does the expected benefit of your device, when following the intended use, outweigh the inherent risks? Our Clinical Specialists know how to answer this question in the most efficient way. They navigate this delicate process, define the optimal route for collection of Clinical Data to get market approval and to access clinical safety and performance throughout the complete lifecycle of your product.
Contact us todayTo bring your innovation to the market include various legal liability issues, associated with being a (legal) ‘manufacturer’ as is directed by the MDR and FDA regulations. This has nothing to do with intellectual property, branding or ownership; it is the formal legal responsibility, that is directly linked with the entity that develops, manufactures and delivers a medical device for use to the market. At BAAT we know what it means to bear this responsibility because we are able to formally act as legal manufacturer on behalf of our customers. We can help you to identify and solve liability issues throughout the manufacturing chain, put the right insurance coverage in place and make sure that all quality agreements are properly connected.
Contact us todayTo ensure a successful collaboration, we strive to understand your goals and business opportunities and get clear how our services fit best in your journey. With our 20+ years of experience we understand the dynamics of getting an idea to the medical device market. We will help you formulate the right strategy for device development, manufacturing, regulatory affairs, safety questions, clinical trials and legal obligations to get your medical device approved in the EU and US. Together we define and refine the crucial steps to reach your milestones.
Contact us todayYou probably know that regulatory affairs is an important piece of your medical devices puzzle. Which rules apply for your project in order to get approval from FDA and MDR? You want to be fully covered and know about existing and upcoming changes in regulations. Be smart and do not go reinventing the wheel. Instead make use of our proved ISO 13485 certified Quality Management System. This system is specially built to assure compliance from approval throughout the complete lifecycle of your product. We designed our QMS to ensure a fluent transfer and be linked to you own processes easily.
Contact us today
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.”
BSN Medical | 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.”
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 todays and tomorrows market environment. The INNOVATE process was very insightful. It helped us define and decide what is necessary to fulfil 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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