Startup Funding BAAT Medical
BAAT Medical - From medical idea to market success
BAAT Medical Develop your product
Assure compliance to MDR - FDA
Medical Device Operations
Clinical Investigation - Roles & Responsibilities
BAAT Medical CE Marking
BAAT Medical passed the ISO 13485 recertification audit

From vision to reality, your end-to-end partner

Funding

Secure the capital to bring your medical device to market

Turning an innovative medical device into a commercial success starts with the right funding strategy. Whether you’re a single entrepreneur, an early stage startup or a technology transfer office, we provide comprehensive funding support to get you the financial backing you need. Our expertise includes:

  • Investment Strategy
  • Startup Fundraising
  • Exclusive Partnership Programs

Why choose us to secure your Funding?

We offer various funding solutions, especially for startups in a very early stage. With BAAT, you’re not just chasing capital; you’re building a financial foundation for success.

Contact us today

Strategy

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 know how to take every step as we do this on a daily basis. From crafting your strategy, developing your product, streamlining manufacturing and delivering your product everywhere while ensuring ongoing compliance. With BAAT, your vision doesn’t just take shape, it thrives.

Contact us today

Development

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 (of Demonstrators)
  • Industrial Design
  • Verification & validation testing
  • Risk Management
  • Intellectual Property
  • Packaging & Labelling
  • eIFU (Electronic Instructions for Use)
  • Project Management

Why choose us for Development?

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.

Contact us today

Manufacturing

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
  • Legal Manufacturing
  • Production Process Development
  • Material Sourcing & Supply Chain Setup
  • Prototype-to-Production Transition
  • Good Manufacturing Practices

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.

Contact us today

Operations

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.

Contact us today

Clinical Evaluation & PMS

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
  • Medical Ethics Comity Submission
  • PMCF (Post-Market Clinical Follow-Up)
  • PMS (Post-Market Surveillance)
  • PSUR (Periodic Safety Update Reports)
  • SSCP (Summary of Safety and Clinical Performance)
  • KOLs (Key Opinion Leaders)
  • Vigilance

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.

Contact us today

Regulatory Affairs

How to navigate the regulatory maze with confidence

Getting your medical device approved and compliant is complex. Our regulatory affairs expertise clears the path to market entry. We handle essential aspects like:

  • MDR CE certification
  • FDA Listing
  • IVDR Compliance
  • 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.

Contact us today

Quality Assurance

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
  • CE MDR Compliance
  • 21CFR820 Compliance
  • Quality Management System (QMS)
  • Design Control
  • Data Management

Why choose us for Quality Assurance?

You can use our Quality Management System that is compliant to CE and FDA requirements where either we can take Legal Responsibility, or we help you how you can become the Legal Manufacturer. We now what is needed for global markets so we embed the right quality into every process, ensuring your device meets the standards with robust systems and meticulous oversight. With us, excellence is guaranteed.

Contact us today

Secure the capital to bring your medical device to market

Turning an innovative medical device into a commercial success starts with the right funding strategy. Whether you’re a single entrepreneur, an early stage startup or a technology transfer office, we provide comprehensive funding support to get you the financial backing you need. Our expertise includes:

  • Investment Strategy
  • Startup Fundraising
  • Exclusive Partnership Programs

Why choose us to secure your Funding?

We offer various funding solutions, especially for startups in a very early stage. With BAAT, you’re not just chasing capital; you’re building a financial foundation for success.

Contact us today

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 know how to take every step as we do this on a daily basis. From crafting your strategy, developing your product, streamlining manufacturing and delivering your product everywhere while ensuring ongoing compliance. With BAAT, your vision doesn’t just take shape, it thrives.

Contact us today

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 (of Demonstrators)
  • Industrial Design
  • Verification & validation testing
  • Risk Management
  • Intellectual Property
  • Packaging & Labelling
  • eIFU (Electronic Instructions for Use)
  • Project Management

Why choose us for Development?

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.

Contact us today

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
  • Legal Manufacturing
  • Production Process Development
  • Material Sourcing & Supply Chain Setup
  • Prototype-to-Production Transition
  • Good Manufacturing Practices

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.

Contact us today

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.

Contact us today

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
  • Medical Ethics Comity Submission
  • PMCF (Post-Market Clinical Follow-Up)
  • PMS (Post-Market Surveillance)
  • PSUR (Periodic Safety Update Reports)
  • SSCP (Summary of Safety and Clinical Performance)
  • KOLs (Key Opinion Leaders)
  • Vigilance

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.

Contact us today

How to navigate the regulatory maze with confidence

Getting your medical device approved and compliant is complex. Our regulatory affairs expertise clears the path to market entry. We handle essential aspects like:

  • MDR CE certification
  • FDA Listing
  • IVDR Compliance
  • 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.

Contact us today

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
  • CE MDR Compliance
  • 21CFR820 Compliance
  • Quality Management System (QMS)
  • Design Control
  • Data Management

Why choose us for Quality Assurance?

You can use our Quality Management System that is compliant to CE and FDA requirements where either we can take Legal Responsibility, or we help you how you can become the Legal Manufacturer. We now what is needed for global markets so we embed the right quality into every process, ensuring your device meets the standards with robust systems and meticulous oversight. With us, excellence is guaranteed.

Contact us today