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 consulting engineer demonstrating arm brace

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.

Baat Medical services overview

Innovate

We can maximize your impact

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R & D

We can develop your product

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Operations

We can supply your product

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Legal Manufacturer

We can take responsibility for your
product

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Innovate

We can maximize your impact

How do you know which ideas are successful in the future? By asking smart questions, we find out together how to maximize your impact.

R & D

We can develop your product

How to meet technical specifications? What regulatory pathway should be taken? We know all about design, engineering and validation, and understand what is needed to pass the notified body and the FDA.

Operations

We can supply your product

How to meet increasing requirements for product delivery? We streamline operations, ensure traceability and handle post market surveillance.

Legal Manufacturer

We can take responsibility for your
product

How to comply with the ever increasing demands from notified bodies? We take responsibility and can be your legal manufacturer.

How do you know which ideas are successful in the future? By asking smart questions, we find out together how to maximize your impact.

How to meet technical specifications? What regulatory pathway should be taken? We know all about design, engineering and validation, and understand what is needed to pass the notified body and the FDA.

How to meet increasing requirements for product delivery? We streamline operations, ensure traceability and handle post market surveillance.

How to comply with the ever increasing demands from notified bodies? We take responsibility and can be your legal manufacturer.

ISO 13485 Baat Medical Device Consulting Services

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.

Demonstrating a surgical implant for medical device consulting

Contact
our expert

medical device design consultancy, new business developer, Dymphy van der Wilk, Baat Medical

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baat customer quotes - medical device innovation

Our Customers About Us

Picture of Nancy Lamerigts - InSpine Orthopedics developments
Nancy Lamerigts MD PhD
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.
Oliver Hass, Essity, is a Baat Medical customer
Dr. Oliver Hass
BSN Medical | Essity
A great 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.
Dr Hans Joachim Fischer-Baat Medical Engineering brings medical innovations to market. Commercial viability is a leading metric in medical device innovation succes.-Baat Medical Engineering brings medical innovations to market.
Dr. Hans-Joachim Fischer
Waldemar Link
The engineering services of Baat really complements our own design process, while seamlessly integrating into our existing operations.
Photo of a Customer of Baat Medical, Medical Device Innovation Design
Pablo Enriquez
Belfry Medical GmbH
Successful products are not made only of great ideas; they require a good understanding of todays and tomorrows market environment. INNOVATE helped us to decide what is necessary to fulfil all stakeholders’ present and future requirements for a high impact product and treatment. BAAT did a great job!
Guntmar Eisen, a Baat Medical customer
Guntmar Eisen
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.
Ariaan-van-Walsum-Baat Medical Engineering brings medical innovations to market. Commercial viability is a leading metric in medical device innovation succes.
Ariaan D.P. van Walsum
Trauma Surgeon, MST Enschede
Baat Medical has made my idea come true. It really contributes to better care for the patient, and to the convenience of surgeons. It's great to work together to realize a medical innovation. I can recommend Baat 100% to surgeons and hospitals that really want to make a move.