Mastering the Medical device Business – since 1999
Starting as a spin-off out of Twente University, Baat has grown into a recognised full- service specialist in product development for the (orthopaedic) medical device market across the world. We currently employ 35+ people with various fields of expertise.
Would you like to download our ISO certifications, patents, scientific papers, or White Papers? You can find them here:
Our Mission - impact in healthcare
When you transform your idea into a medical device or application, you will encounter a number of hurdles. Our mission is to navigate you through the intricacies of developing, approving and marketing your product. We help your company create impact in healthcare, as well as making your product(s) commercially viable. Wether you are a startup with or without funding, an expert in the field of (orthopedic) implants, or need help securing your IP or manage quality and risk management. Our 300+ product developments (and counting) make us your go-to partner in the medical device development business. Curious? Jump on a call with us or request a quotation.
Use our Quality Management System
You can use our 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.
Getting your Medical Products to Market
We help medical startups and (orthopedic) entrepreneurs get their products to market. You can count on our company for medical device design consultancy, development consulting, regulatory consulting, device marketing strategy, quality testing and consulting.
Many of our customers want to collaborate confidently with us, controlling their IP and protecting and growing their potential in this business. As a full-service partner for you, we are about delivering medical device regulatory consulting services, as well as drawing reports; but we aim for creating a meaningful impact on the lives of patients.
It’s all about quality (and the system)
Even the best and most experienced medical device 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 a team of experts in medical product engineering is not enough; they must use a thorough quality management system to get regulatory approval for a medical device.