Expertise at your fingertips
Do you have great ideas for 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 implant development. BAAT has the experience and know-how to transform your implant innovation into a product with manufacturing route, CE/FDA application and operations.
How to come to an (orthopedic) implant design?
Design of implants is applying design principles for healthcare purposes, specifically those implanted in the body. During the journey from idea to implant there are important questions to answer:
- What concept works for all users (patient, OR assistant, surgeon, etc.)?
- How can all users safely and effectively use the implant?
- How can the implant body design, production process and packaging be fully specified?
- Who can work together to make it?
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Spinal implant body design
BAAT implant design, engineering by Baat Medical
Overcome hurdles during implant innovations
When you transform your implant innovation into an approved 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 implant development and get your implant design approved for market introduction. Other questions for a successful product development and design are:
- How can we prove safety and performance of the implant design for the patient and other users?
- What strategy and information will lead to market approval?
- How can we ensure the implant is fully monitored and traceable from raw material to clinical use?
- How is the clinical performance of the implants tracked and continued access to the market ensured?
Implant development: it’s all about the system
Even the best implant design engineers 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 implant development and design (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.
Contact us for questions- +31-88-5656600
Experience matters
BAAT has been the go-to company for implant design, development and innovation for many customers for over two decades. It is not just about drawing a femoral stem design or testing an implant collar design; it is about creating a meaningful impact on the lives of patients. As your full-service implant development company, we’re partners for the complete journey and are only satisfied when your implant is successfully treating patients.
X-ray of Hip implant design for femoral neck fractures
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Baat offers an extensive list of patents and scientific publications on the general company page. Go to Company Page
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Contact us to reach your goals
Use our expertise in implant design to reach your goals, while maintaining flexibility. Bring your implant design to market using our solid foundations of expertise, experience and our thorough ISO 13485 quality management system.