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 expert medical device development centre. We have the experience and know-how to transform your dream, idea, technology or problem into a product with manufacturing route, CE/FDA application and operations.
Medical Design Companies
Medical device product development companies apply engineering principles for healthcare purposes. BAAT has been the go-to medical device development firm 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 medical design 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?
Medical Development of an Arm Brace
Medical device development companies contribute to treating patients with a new arm brace.
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Creating a meaningful impact on the lives of patients
When you transform your idea into a medical device you will encounter hurdles. BAAT is successfully guiding customers to overcome these hurdles since 1999. Use our experience to navigate the intricacies of developing your product and getting it 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?
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Medical devices: it’s all about the system
Even the best and most experienced medical device development 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.
ISO 13485 quality system
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.
- Verification and validation
- Risk management
- Control of documents
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Baat is a full-service specialist in medical product development.
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Our Medical Product Portfolio tells our story best.
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With 25+ Products to market, we are proud to list our customers Patents.
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We contribute to scientific publications on a regulary.
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Medical Device Consulting | How to get Market Approval?
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BAAT: more than a Medical Product Design firm
When you transform your idea into a medical device you will encounter hurdles. BAAT is successfully guiding customers to overcome these hurdles since 1999. Use our experience to navigate the intricacies of developing your product and getting it approved for market introduction. Unlike medical product design companies, for us, creating a design for your device is just the start. As your full-service medical device development firm, we’re partners for the complete journey and are only satisfied when your product is successfully treating patients.
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. Use our medical device 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.