Medical device R&D
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.
Human factors medical devices
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:
- What concept works for all users (patient, OR assistant, surgeon, etc.)?
- How can all users safely and effectively use the medical device (human factors medical devices)?
- How can the design, production process and packaging be fully specified?
- Who can work together to make it?
- 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
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.
