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.
At BAAT Medical, we guide you in looking ahead to a prosperous future. Together, we will identify key stakeholders, assess external factors, and craft a compelling business case. Our 20+ years of experience in the medical device sector ensures that your journey from concept to market is both visionary and grounded, setting clear milestones and budgets. Partner with us to define and refine your business strategy, leveraging our deep industry knowledge for your success.
Contact us todayAt BAAT Medical, our journey to market readiness is defined by a controlled, transparent process. We integrate design, engineering, and risk management with rigorous verification and validation. Selecting the finest in the supply chain and ensuring comprehensive user information, we uphold the highest standards of clinical evaluation. Our meticulous technical documentation and a robust Device Master Record (DMR) affirm our compliance with MDR and FDA regulations, setting the stage for your device’s success.
Contact us todayAt Baat Medical, seamless supply chain management is crucial after your product hits the market. We handle order processing, timely deliveries, and engineering change orders with precision. Our operational services are designed to sustain and enhance your product’s market presence. Trust in our comprehensive approach for continuous clinical follow-up and supply chain excellence.
Contact us todayUse the BAAT Quality Management System to accelerate your time to market during development and setting up your supply chain and after launch for your life cycle management. Our Quality Management System is always updated for MDR and FDA regulations.
Contact us todayClinical evidence is more important than ever. We can create your Clinical Evaluation Report and assist setting up clinical trials in US and EU. And after market introduction we keep your technical file up to date with PMS and PSUR.
Contact us todayHow to organize the formal responsibility of being legal manufacturer? And how to keep your device on the market and manage the life cycle of your device? We can be your legal manufacturer while you hold your identity and IP.
Contact us todayAt BAAT Medical, we guide you in looking ahead to a prosperous future. Together, we will identify key stakeholders, assess external factors, and craft a compelling business case. Our 20+ years of experience in the medical device sector ensures that your journey from concept to market is both visionary and grounded, setting clear milestones and budgets. Partner with us to define and refine your business strategy, leveraging our deep industry knowledge for your success.
Contact us todayAt BAAT Medical, our journey to market readiness is defined by a controlled, transparent process. We integrate design, engineering, and risk management with rigorous verification and validation. Selecting the finest in the supply chain and ensuring comprehensive user information, we uphold the highest standards of clinical evaluation. Our meticulous technical documentation and a robust Device Master Record (DMR) affirm our compliance with MDR and FDA regulations, setting the stage for your device’s success.
Contact us todayAt Baat Medical, seamless supply chain management is crucial after your product hits the market. We handle order processing, timely deliveries, and engineering change orders with precision. Our operational services are designed to sustain and enhance your product’s market presence. Trust in our comprehensive approach for continuous clinical follow-up and supply chain excellence.
Contact us todayUse the BAAT Quality Management System to accelerate your time to market during development and setting up your supply chain and after launch for your life cycle management. Our Quality Management System is always updated for MDR and FDA regulations.
Contact us todayClinical evidence is more important than ever. We can create your Clinical Evaluation Report and assist setting up clinical trials in US and EU. And after market introduction we keep your technical file up to date with PMS and PSUR.
Contact us todayHow to organize the formal responsibility of being legal manufacturer? And how to keep your device on the market and manage the life cycle of your device? We can be your legal manufacturer while you hold your identity and IP.
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.
Trauma Chirurg, MST Enschede
"Baat made sure my idea became a reality. It now really contributes to better patient care, and to surgeons' convenience. Great to work together to make an innovation a reality. I can 100% recommend Baat to surgeons and hospitals who really want to make strides."
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.”
Silony Medical
“I appreciate to work together with you and your company. At the end I’m happy with the outcome and I’m looking forward to the market launch. I appreciate the support of you and your company with a lot of experience. Many thanks to you and your team. I would be happy to start a new project in future together with you and I’m looking forward to our cooperation during market phase.”
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!”
New Business Development Global
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