Your Medical Device. Our Expertise.

Medtech Market Access: From Innovative Idea to Compliant Medical Device

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.

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BAAT Medical - From medical idea to market success

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BAAT Medical passed the ISO 13485 recertification audit

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From Innovative Idea to Continued Medtech Market Access

Startup Funding

Are you an Entrepreneur on a mission? Then, we offer you a no cure no pay service so you can get funding secured to develop your Innovative Idea into a real Medical Device using our Qualified Medical Device Service Package.

Medical device design

Accelerate your time-to-market with our innovative thinking approach and proven, structured process, while we guide you through every stage—from concept and development to manufacturing, regulatory approval, quality assurance and market launch.

Manufacturing

From prototype to scale up, we create a flexible, cost-effective supply chain with access to our network of trusted, high-quality suppliers.

Certification

Navigate global regulatory requirements to secure certification through our regulatory expertise and ISO-standard compliance.

Quality Assurance

Use our Quality Management System (compliant to ISO 13485, MDR and approved by a US Multinational) to get Market Access for your Medical Device.

Vigilance and PMS

Prove your device’s value with clinical data that highlights patient benefits, resonates with investors, and aligns with market needs.

Legal Manufacturer

Minimize legal risks with our comprehensive support in warehousing, distribution, post-market surveillance and change control. Do you prefer to be the Legal Manufacturer yourself? We have a lean QMS service that enables you to do this.

From prototype to scale up, we create a flexible, cost-effective supply chain with access to our network of trusted, high-quality suppliers.

Navigate global regulatory requirements to secure certification through our regulatory expertise and ISO-standard compliance.

Use our Quality Management System (compliant to ISO 13485, MDR and approved by a US Multinational) to get Market Access for your Medical Device.

Prove your device’s value with clinical data that highlights patient benefits, resonates with investors, and aligns with market needs.