Let’s transform your innovative medical device idea into market success. You benefit (“BAAT” in Dutch) from our hands-on knowledge and experience. Use our innovative thinking approach and proven, structured process, while we guide you through every stage—from concept and development to manufacturing, regulatory approval for the Global Market, quality assurance, market launch, and ongoing compliance, including post-market surveillance (PMS). You navigate the complex regulatory landscape with confidence and obtain a strong position in the competitive healthcare market.
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 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 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 deliver your medical device at your users
Once your medical device hits the market, success hinges on seamless operations. Our services keep your supply chain humming and your product compliant, with expertise in:
• Supplier Management & Audits
• Warehousing & Inventory Control
• Traceability & ERP Systems
• Handling Non-Conformities (NCs)
• Logistics & Distribution
Why partner with us for Operations?
We take charge of the details — auditing suppliers, tracking every unit, and resolving issues — so your product stays reliable and available.
It’s not just about maintenance; it’s about mastery in motion.
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 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 ensure end-to-end Quality
Quality is the foundation of a successful medical device. Our quality assurance services safeguard your product’s integrity from vision to reality. We focus on critical elements like:
• ISO 13485 Compliance
• Quality Management System (QMS)
• Design Control
• Data Management
Why choose us for Quality Assurance?
We embed quality into every process, ensuring your device meets the standards with robust systems and meticulous oversight. With us, excellence is guaranteed.
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 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 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 deliver your medical device at your users
Once your medical device hits the market, success hinges on seamless operations. Our services keep your supply chain humming and your product compliant, with expertise in:
• Supplier Management & Audits
• Warehousing & Inventory Control
• Traceability & ERP Systems
• Handling Non-Conformities (NCs)
• Logistics & Distribution
Why partner with us for Operations?
We take charge of the details — auditing suppliers, tracking every unit, and resolving issues — so your product stays reliable and available.
It’s not just about maintenance; it’s about mastery in motion.
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 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 ensure end-to-end Quality
Quality is the foundation of a successful medical device. Our quality assurance services safeguard your product’s integrity from vision to reality. We focus on critical elements like:
• ISO 13485 Compliance
• Quality Management System (QMS)
• Design Control
• Data Management
Why choose us for Quality Assurance?
We embed quality into every process, ensuring your device meets the standards with robust systems and meticulous oversight. With us, excellence is guaranteed.
