Medical Device Consulting

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.

When do I need a medical consulting firm?

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.

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Medical Device Consultancy or Partnership?

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?

Medical device consulting roadmap for startups

Your medical device consulting journey starts here

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.

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Medical Device Consultancy - ID 6

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BAAT Medical Develop your product
BAAT Medical monitor patient safety
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BAAT Medical - From medical idea to market success
Assure compliance to MDR - FDA

Manage your supply chain

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

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Develop your product

Accelerate time-to-market with our integrated development process and engineering expertise tailored for MedTech.

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Monitor patient safety

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

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Bear legal responsibility

Minimize legal risks with our comprehensive support in warehousing, distribution, post-market surveillance and change control.

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Define your business

Build a compelling business case to attract investor funding, backed by our 25 years of MedTech expertise and our global industry network.

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Assure compliance to MDR / FDA

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

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

Contact us today

Accelerate time-to-market with our integrated development process and engineering expertise tailored for MedTech.

Contact us today

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

Contact us today

Minimize legal risks with our comprehensive support in warehousing, distribution, post-market surveillance and change control.

Contact us today

Build a compelling business case to attract investor funding, backed by our 25 years of MedTech expertise and our global industry network.

Contact us today

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

Contact us today

Baat-company-overview-ISO-BADGE-Medical-Device-Consulting-Certification-ISO-13485

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.

Experience matters

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.

Reach your goals

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.

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