Do you have a great idea for a medical device and need a partner to realize it and make it ready for market approval? Is your development portfolio bigger than your R&D department’s capacity?
BAAT is your partner in expert medical device design engineering. 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.
Medical device engineering is applying engineering principles for healthcare purposes. It is not just calculations, drawings and tolerances; it is about creating a meaningful impact on the lives of patients. During the journey from idea to product there are important questions to answer, many of them not of technical nature:
Asking the right questions is the first step to a successful project. Having impact on the end user means impact in the market. Some examples:
One of the steps many customers do is answering above questions using an Innovation Scan. We call it ‘Innoscan’. Get in contact with Baat to see what can lead to a commercially viable product development and real impact in the medical device business.
To 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 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 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 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 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 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 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 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 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 today
Our ISO 13485 quality system (certificates) 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+ people with various fields of expertise, our expertise with medical device engineering for both the EU and US markets with 30+ products developed (publication list), but also of our underlying quality system.
Even the best and most experienced medical device design engineers 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 experts in medical product engineering is not enough; they must use a thorough quality management system to get regulatory approval for a medical device.
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!”
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