Do you have a great idea for an orthopedic design, or specific an orthopedic implant 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 orthopedic design. 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.
Design of orthopedic implants?
Design of orthopedic implants is applying design principles for healthcare purposes, specifically treating issues related to the musculoskeletal system. BAAT has been the go-to company for orthopedic design and technology for many customers for over two decades. For us, it is not just about drawings, tests and technologies; it is about creating a meaningful impact on the lives of patients.
During the journey from idea to product there are important questions to answer:
- What orthopedic 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?
When you transform your orthopedic design & technology into a medical device you will encounter hurdles. BAAT is successfully guiding customers to overcome these hurdles since 1999. Use this experience to navigate the intricacies for your orthopedic development and get your device approved for market introduction.
- 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?
Orthopedic development
It’s all about the system
Even the best and most designers of orthopedic implants 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 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 orthopedic design and technology (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 development company, we’re partners for the complete journey and are only satisfied when your orthopedic design & technology is successfully treating patients.
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Contact us to reach your goals
The activities are aimed at providing safe and effective medical devices for patients, but as legal manufacturer they can be quite a burden on your resources. BAAT can help out; we’ve developed a cooperation model for all operational services involved with bringing and keeping a medical device on the market. This collaboration can come in various forms, in all cases BAAT effectively covers the foundations to meet the regulatory requirements, so you can maintain flexibility. Contact us today to define how you want to cooperate.
- 25+ Products to Market
- 20+ Years of Experience
- Full-service Provider
- In House Experts
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