Medical device design
Do you have great ideas for medical device design 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 design and development. BAAT has the experience and know-how to transform your idea into a medical device with manufacturing route, CE/FDA application and operations.
Medical device design at your fingertips
Design of medical devices is applying design principles for healthcare purposes. BAAT has been the go-to company for medical device design and development for many customers for over two decades. For us, it is not just about industrial design sketches, calculations and tests; it is about creating a meaningful impact on the lives of patients.
- What concept works for all users (patient, OR assistant, surgeon, etc.)?
- How can all users safely and effectively use the medical device? Is it appealing (industrial design medical instruments)?
- What medical instrument design and medical equipment design does your medical device need to work with to make it a success?
- How can the device design, production process and packaging be fully specified?
- Who can work together to make it?
- How can we prove safety and performance of the medical instrument design 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 medical device tracked and continued access to the market ensured?
When you transform your idea into an approved biomedical device design you will encounter hurdles. BAAT is successfully guiding customers to overcome these hurdles since 1999. Use this experience to navigate the intricacies of your medical device and development and get your product approved for market introduction.
It’s all about the system
Even the best medical device designers are only as good as the quality system they are working under. At least according to the authorities assessing market approval. That means an expert medical industrial design team 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 medical device and 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.
BAAT has created many biomedical device designs for a range of customers since 1999. As your full-service medical device and development company, creating the design is just the start; we are partners for the complete journey and are only satisfied when your medical device is successfully treating patients.
Contact us to reach your goals
Use our expertise in medical device design to reach your goals while maintaining flexibility. Contact us today to get your medical device design on the market using our solid foundations of expertise, experience and our thorough ISO 13485 quality management system.