The subject ‘Orthopedic Engineering’ covers a range of topics including tissue engineering, cell biology, and mechanics. A typical biomedical engineer has knowledge of skeletal muscle mechanics, soft tissue biology, and can assist in the engineering process to develop innovative therapies to treat musculoskeletal disorder.
In the field of orthopedic engineering, one would apply engineering principles for healthcare purposes, specifically treating issues related to the musculoskeletal system.
Common challenges that orthopedic biomedical engineering companies face:
Even the best and most experienced orthopedic bioengineering company is only as good as it’s quality system. 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 and introduce a medical device into market.
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.
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.
Trauma Chirurg, MST Enschede
BSN Medical | Essity
EIT, a J&J company
Belfry Medical GmbH
“Making your product a success is my biggest goal!”