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.

Contact our expert

Medical Device Consultancy - ID 6

BAAT Medical - From medical idea to market success

Manage your supply chain

At Baat Medical, seamless supply chain management is crucial after your product hits the market. We handle order processing, timely deliveries, and engineering change orders with precision. Our operational services are designed to sustain and enhance your product’s market presence. Trust in our comprehensive approach for continuous clinical follow-up and supply chain excellence.

Develop your product

At BAAT Medical, our journey to market readiness is defined by a controlled, transparent process. We integrate design, engineering, and risk management with rigorous verification and validation. Selecting the finest in the supply chain and ensuring comprehensive user information, we uphold the highest standards of clinical evaluation. Our meticulous technical documentation and a robust Device Master Record (DMR) affirm our compliance with MDR and FDA regulations, setting the stage for your device’s success.

Monitor patient safety

Clinical evidence is more important than ever. We can create your Clinical Evaluation Report and assist setting up clinical trials in US and EU. And after market introduction we keep your technical file up to date with PMS and PSUR.

Bear legal responsibility

How to organize the formal responsibility of being legal manufacturer? And how to keep your device on the market and manage the life cycle of your device? We can be your legal manufacturer while you hold your identity and IP.

Define your business

At BAAT Medical, we guide you in looking ahead to a prosperous future. Together, we will identify key stakeholders, assess external factors, and craft a compelling business case. Our 20+ years of experience in the medical device sector ensures that your journey from concept to market is both visionary and grounded, setting clear milestones and budgets. Partner with us to define and refine your business strategy, leveraging our deep industry knowledge for your success.

Assure compliance to MDR / FDA

Use the BAAT Quality Management System to accelerate your time to market during development and setting up your supply chain and after launch for your life cycle management. Our Quality Management System is always updated for MDR and FDA regulations.

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.

Demonstrating a surgical implant for medical device consulting

Our Customers About Us

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 Chirurg, MST Enschede

"Baat made sure my idea became a reality. It now really contributes to better patient care, and to surgeons' convenience. Great to work together to make an innovation a reality. I can 100% recommend Baat to surgeons and hospitals who really want to make strides."

Dr. Hans-Joachim Fischer

Waldemar Link

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

Oliver Hass, Essity, is a Baat Medical customer

Dr. Oliver Hass

BSN Medical | Essity

“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.”

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.”

Katharina Barsch

Silony Medical

“I appreciate to work together with you and your company. At the end I’m happy with the outcome and I’m looking forward to the market launch. I appreciate the support of you and your company with a lot of experience. Many thanks to you and your team. I would be happy to start a new project in future together with you and I’m looking forward to our cooperation during market phase.”

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."

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. 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!”

Medical Device Consulting

When do I need a medical consulting firm?

Medical Device Consultancy or Partnership?

Your medical device consulting journey starts here

Contact our expert