We offer a full spectrum of services to develop and manufacture your medical device according the MDR and FDA regulations. Our multidisciplinary team is looking forward to collaborate with you and support you in reaching your goal.
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 todayWhat experience do you have in medical device development? What investments are needed up-front and what is needed to expand your reach within the market? We know what is needed to develop a medical device, stand out and secure the path to succesful and profitable medical innovation.
So you can focus on sales while maintaining flexibility. We will use our expertise in medical device development to get market approval for your device while you hold IP. Contact us today to use our solid foundations of experience and our established ISO 13485 quality management system.
Check also our Whitepaper on why it can be interesting for you to Outsource your Medical Product Development
