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.
Medical device R&D: It’s all about the system
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.
Our ISO 13485 quality system (certificates) reads like a medical device R&D handbook.
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:
- How can we prove safety and performance for the patient and other users?
- What strategy and information will lead to market approval?
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.
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