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 is your expert medical device development centre. We have 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 Design Companies
Medical device product development companies apply engineering principles for healthcare purposes. BAAT has been the go-to medical device development firm for many customers for over two decades. For us, it is not just about designs, tests and drawings; it is about creating a meaningful impact on the lives of patients.
During the journey from idea to product medical design companies face important questions:
- What concept works for all users (patient, OR assistant, surgeon, etc.)?
- How can all users safely and effectively use the medical device?
- How can the design, production process and packaging be fully specified?
- Who can work together to make it?
Creating a meaningful impact on the lives of patients
When you transform your idea into a medical device you will encounter hurdles. BAAT is successfully guiding customers to overcome these hurdles since 1999. Use our experience to navigate the intricacies of developing your product and getting it approved for market introduction.
- How can we prove safety and performance for the patient and other users?
- What strategy and information will lead to market approval?
- How can we ensure the medical device is fully monitored and traceable from raw material to clinical use?
- How is the clinical performance of the products tracked and continued access to the market ensured?
Medical devices: it’s all about the system
Even the best and most experienced medical device development group is only as good as the quality system it is working under. At least according to the authorities assessing market approval. That means an expert team is not enough; they must use a thorough quality management system to get regulatory approval for a medical device.
ISO 13485 quality system
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.
- Verification and validation
- Risk management
- Control of documents
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 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.Katharina BarschSilony Medical
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.”
BAAT: more than a Medical Product Design firm
When you transform your idea into a medical device you will encounter hurdles. BAAT is successfully guiding customers to overcome these hurdles since 1999. Use our experience to navigate the intricacies of developing your product and getting it approved for market introduction. Unlike medical product design companies, for us, creating a design for your device is just the start. As your full-service medical device development firm, we’re partners for the complete journey and are only satisfied when your product is successfully treating patients.
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. 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.