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.
How to craft your medical device with precision
Turning your medical device concept into reality requires more than just equipment—it demands a robust, efficient process. Our manufacturing services focus on building your product at scale, ensuring quality and readiness for market approval. We handle critical elements like:
• Design for Manufacturing
• Supplier Selection & Evaluation
• Selecting a Legal Manufacturer
• Production Process Development
• Material Sourcing & Supply Chain Setup
• Prototype-to-Production Transition
Why choose us for Manufacturing?
We optimize every stage—from refining your design for production to selecting reliable suppliers—ensuring your device is built with precision and efficiency. Your vision isn’t just produced; it’s perfected for the next step.
How to turn your vision into reality
Turning a medical device concept into a tangible, market-ready product takes knowledge and experience. Our comprehensive development services guide you from initial idea to market-ready product, ensuring every detail aligns with your vision. Our development service includes critical areas like:
• Concept Development
• Needs & Requirements
• Usability
• Prototyping
• Industrial Design
• Verification & validation testing
• Risk Management
• Intellectual Property
• Packaging & Labelling
• eIFU (Electronic Instructions for Use)
• Project Management
Why Develop your medical device with us?
We get your vision into reality with our proven process—covering everything from innovative design to regulatory-compliant solutions. With our support, your product doesn’t just get built — it stands out.
How to prove your device delivers
Demonstrating safety and efficacy is critical to your medical device’s success. Our clinical evaluation services provide the evidence you need to stand out. We cover vital areas like:
• Clinical Strategy
• Clinical Trials
• PMCF (Post-Market Clinical Follow-Up)
• PMS & Vigilance (Post-Market Surveillance)
• PSUR (Periodic Safety Update Reports)
• KOLs (Key Opinion Leaders)
Why choose us for Clinical Evaluation?
We design and execute lean evaluations that meet regulatory demands and build trust — turning data into your competitive edge. Your device doesn’t just perform; it proves itself.
How to make real world impact with your medical device
Transforming a medical device idea into a market success requires a clear, actionable strategy. We offer end-to-end support to not only develop your product but also launch and scale it effectively. Our strategic expertise covers areas like:
• Market Research & Market Entry
• Business Case Development
• Key Industry Connections
Why choose us to shape your strategy?
We manage every step — from crafting your strategy, developing your product, streamlining manufacturing and ensuring ongoing compliance. With BAAT, your vision doesn’t just take shape – it thrives.
How to navigate the regulatory maze with confidence
Getting your medical device approved and compliant is complex — but it doesn’t have to be daunting. Our regulatory affairs expertise clears the path to market entry. We handle essential aspects like:
• MDR CE certification
• FDA Listing
• Regulatory Strategy
• Regulatory Submission
• PRRC (Person Responsible for Regulatory Compliance)
• Compliance Remediation
Why choose us for Regulatory Affairs?
We simplify complexity, aligning your medical device with global regulations and accelerating approvals. With our guidance, compliance becomes a strength, not a hurdle.
How to craft your medical device with precision
Turning your medical device concept into reality requires more than just equipment—it demands a robust, efficient process. Our manufacturing services focus on building your product at scale, ensuring quality and readiness for market approval. We handle critical elements like:
• Design for Manufacturing
• Supplier Selection & Evaluation
• Selecting a Legal Manufacturer
• Production Process Development
• Material Sourcing & Supply Chain Setup
• Prototype-to-Production Transition
Why choose us for Manufacturing?
We optimize every stage—from refining your design for production to selecting reliable suppliers—ensuring your device is built with precision and efficiency. Your vision isn’t just produced; it’s perfected for the next step.
How to turn your vision into reality
Turning a medical device concept into a tangible, market-ready product takes knowledge and experience. Our comprehensive development services guide you from initial idea to market-ready product, ensuring every detail aligns with your vision. Our development service includes critical areas like:
• Concept Development
• Needs & Requirements
• Usability
• Prototyping
• Industrial Design
• Verification & validation testing
• Risk Management
• Intellectual Property
• Packaging & Labelling
• eIFU (Electronic Instructions for Use)
• Project Management
Why Develop your medical device with us?
We get your vision into reality with our proven process—covering everything from innovative design to regulatory-compliant solutions. With our support, your product doesn’t just get built — it stands out.
How to prove your device delivers
Demonstrating safety and efficacy is critical to your medical device’s success. Our clinical evaluation services provide the evidence you need to stand out. We cover vital areas like:
• Clinical Strategy
• Clinical Trials
• PMCF (Post-Market Clinical Follow-Up)
• PMS & Vigilance (Post-Market Surveillance)
• PSUR (Periodic Safety Update Reports)
• KOLs (Key Opinion Leaders)
Why choose us for Clinical Evaluation?
We design and execute lean evaluations that meet regulatory demands and build trust — turning data into your competitive edge. Your device doesn’t just perform; it proves itself.
How to make real world impact with your medical device
Transforming a medical device idea into a market success requires a clear, actionable strategy. We offer end-to-end support to not only develop your product but also launch and scale it effectively. Our strategic expertise covers areas like:
• Market Research & Market Entry
• Business Case Development
• Key Industry Connections
Why choose us to shape your strategy?
We manage every step — from crafting your strategy, developing your product, streamlining manufacturing and ensuring ongoing compliance. With BAAT, your vision doesn’t just take shape – it thrives.
How to navigate the regulatory maze with confidence
Getting your medical device approved and compliant is complex — but it doesn’t have to be daunting. Our regulatory affairs expertise clears the path to market entry. We handle essential aspects like:
• MDR CE certification
• FDA Listing
• Regulatory Strategy
• Regulatory Submission
• PRRC (Person Responsible for Regulatory Compliance)
• Compliance Remediation
Why choose us for Regulatory Affairs?
We simplify complexity, aligning your medical device with global regulations and accelerating approvals. With our guidance, compliance becomes a strength, not a hurdle.
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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