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 partner in expert medical device R&D. 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.
R&D for medical devices is not just calculations, drawings and tolerances; it is about creating a meaningful impact on the lives of patients. During the journey from idea to product there are important questions to be answered covering many fields of expertise:
Since 1999 BAAT has faced AND successfully answered these questions for many customers developing medical devices. Partner up and use this experience to navigate the intricacies of evolving your products from concepts to validated solutions approved for market introduction.
Even the most experienced people working medical device R&D jobs 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 R&D engineers for medical devices 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) reads like a medical device R&D handbook. It 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+ people with various fields of expertise, but also of our underlying quality system. This makes BAAT an excellent partner to completely outsource medical product research and development versus investing in organizing all activities, responsibilities and quality management system in house.
KneeRevivor, Research and Development for Arthrosave
https://www.arthrosave.com/
Information about the safety and performance of your medical R&D development must be widely available. What concept works for all users (patient, surgeon, etc.) and how can all users safely and effectively use the innovative medical device (human factors medical devices)? Key factors to look out for are:
Use our medical device R&D 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.
Paradigm Spine
“The way BAAT Medical organizes projects and handles our requests is absolutely great. They have a structured approach that ensures everything runs smoothly and efficiently. One of the standout aspects is their ability to manage topics and make decisions internally, only seeking my input when absolutely necessary. This has not only saved me a tremendous amount of time but also instilled a great deal of confidence in their expertise and professionalism. I highly recommend BAAT Medical to anyone looking for a reliable and proficient partner.”
Waldemar Link
“The engineering services of Baat really complements our own design process, while seamlessly integrating into our existing operations.”
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.”
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.”
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."
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!”
“Making your product a success is my goal.”
Business development