Medical Device Consulting

Do you have a great idea for a medical device and need a partner to realize it and make it ready for market approval? 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.

Medical device design consultancy or partnership?

During the journey from idea to product there are important topics to address, each with their own flavor of “Medical Device Consultants Inc.”: design consultants, development consultants, strategy consultants, regulatory consultants, reimbursement consultants, quality consultants. Is that what you actually need? Or do you want to collaborate confidently with one partner who has it all under control? As your full-service partner we’re not just about delivering medical device regulatory consulting, a drawing or report; we care about creating a meaningful impact on the lives of patients.

Call our New Business Developer (Dymphy) now:+31885656600

Medical device consulting for spine

Medical devices: it’s all about the system

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 (certificates) 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.

“Making your product a success is my biggest goal.”

DymphyBusiness Developer | Baat Medical

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.

Contact us to 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.

The activities are aimed at providing safe and effective medical devices for patients, but as legal manufacturer they can be quite a burden on your resources. BAAT can help out; we’ve developed a cooperation model for all operational services involved with bringing and keeping a medical device on the market. This collaboration can come in various forms, in all cases BAAT effectively covers the foundations to meet the regulatory requirements, so you can maintain flexibility. Contact us today to define how you want to cooperate.

  • 25+ Products to Market
  • 20+ Years of Experience
  • Full-service Provider
  • In House Experts

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Medical device consultancy for a new arm brace

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Our Customers About Us

“Successful products are not made only of great ideas; they require a good understanding of todays and tomorrows market environment. The INNOVATE process was very insightful. It helped us define and decide what is necessary to fulfil all stakeholders’ present and future requirements in order to have a high impact product and treatment. BAAT did a great job!”

Pablo EnriquezBelfry Medical GmbH

“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.”

Guntmar EisenEIT, a J&J company

“Baat heeft gezorgd dat mijn idee werkelijkheid is geworden. Het draagt nu echt bij aan betere zorg voor de patient, en aan het gemak van chirurgen. Geweldig om samen te werken aan het realiseren van een innovatie. Ik kan Baat 100% aanbevelen aan chirurgen en ziekenhuizen die echt stappen willen maken.”

Ariaan D.P. van WalsumTrauma Chirurg, MST Enschede

“The engineering services of Baat really complements our own design process, while seamlessly integrating into our existing operations.”

Dr. Hans-Joachim FischerWaldemar Link

“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. Oliver HassBSN Medical

“I would be happy to start another project in future and I’m looking forward to our further cooperation.”

Katharina BarschSilony Medical