The question you’re answering defines what medical device prototyping is needed and how much effort medical device prototype development requires. A prototype is a version of your medical device that allows you to review and investigate the design. One of the medical device development tools that supports the iterative nature of the process is medical device prototyping. How can we ensure that the device fulfils the user needs? Or, according to the FDA: ‘Did we design the right device?’.How can we prove the specified design (output) meets the requirements (input)? Or, according to the FDA: ‘Did we design the device right?.What attributes and characteristics describe the device, packaging and information that comes with it?.How can the device fulfil the user needs and requirements?.What must the medical device be capable of? What qualities must it have?.In what environment does it need to work? What do users want to achieve with the medical device?.For design control, medical device development includes the following topics: The goal of the design control process is the reliable design of medical devices, resulting in products that are safe and effective.
They must use a formal medical device development process, with activities focused on design control. Strict design controls for the medical device industry are in place, meaning an expert team is not enough to get regulatory approval for a medical device. At least according to the authorities assessing market approval. Medical device product developmentĮven the best medical device developers are only as good as the medical device development process they are working under. Use this experience to navigate the intricacies of your medical device design and development and get your medical device approved for market introduction. BAAT is successfully guiding customers to overcome these hurdles since 1999. For us, it is not just about industrial design sketches, medical device prototyping it is about creating a meaningful impact on the lives of patients.Īlong the journey from idea to regulatory approval, you will encounter hurdles. BAAT has been the go-to company for medical device development for many customers for over two decades. Medical device development is the process used to transform your idea into an approved medical device that is treating patients. 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 Development Expertise at your fingertipsĭo you have a great idea and need a partner for the design and manufacture of medical devices? Is your development portfolio bigger than your R&D department’s capacity? BAAT is your partner in expert medical device development from prototype to regulatory approval.
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