Expertise at your fingertips
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 orthopedic engineering. 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.
Orthopedic Engineering Companies
Orthopedic engineering is applying engineering principles for healthcare purposes, specifically treating issues related to the musculoskeletal system. BAAT has been the go-to orthopedic engineering company for many customers for over two decades. For us, it is not just about designs, tests and drawings; it is about creating a meaningful impact on the lives of patients.
During the journey from idea to product, orthopedic biomedical engineering companies face important questions:
- What concept works for all users (patient, OR assistant, surgeon, etc.)?
- How can all users safely and effectively use the medical device?
- 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?
Orthopedics and engineering
It’s all about the system
Even the best and most experienced orthopedic bioengineering group is only as good as the quality system it is working under. At least according to the authorities assessing market approval. That means an expert 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 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. 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.
Experience matters
BAAT has created many orthopedic medical devices for a range of customers since 1999. For us, creating a design for your device is just the start. As your full-service orthopedic engineering company, we’re partners for the complete journey and are only satisfied when your product is successfully treating patients. Use our experience to navigate the intricacies of developing your product and getting it approved for market introduction.
Our Customers About Us
Contact us to reach your goals
Use our orthopedic engineering 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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✅ Scientific publications
Browse Publication List >
✅ Regulatory aspects of 3D-printed surgical implants
Regulatory Aspects of Biomedical Engineering