Do you have great ideas for medical product 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 product 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 product design is applying design principles for healthcare purposes. BAAT has been the go-to company for medical product design and development for many customers for over two decades. For us, it is not just about design sketches, calculations and tests; it is about creating a meaningful impact on the lives of patients.
During the journey from idea to completed biomedical product design there are important questions to answer:
When you transform your idea into an approved medical device product design you will encounter hurdles. BAAT is successfully guiding customers to overcome these hurdles since 1999. Use this experience to navigate the intricacies for your medical product design and development and get your product approved for market introduction.
Even the best medical product 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 design team is not enough; they must use a thorough quality management system to get regulatory approval for a medical product.
Our ISO 13485 quality system (certificates) concerns topics directly related to medical product design 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 product designs for a range of customers since 1999. For us, creating the design is just the start. As your full-service medical product development company, we’re partners for the complete journey and are only satisfied when your medical product is successfully treating patients.
Use our expertise in medical product design to reach your goals while maintaining flexibility. Contact us today to use our solid foundations of expertise, experience and our thorough ISO 13485 quality management system.
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