We are the world’s best service provider for development and manufacturing of innovative medical devices enabling customers to achieve their goals and patients a longer, active life.
We create BAAT for
We’ve been at the forefront of medical device innovation since 1999. With over two decades of dedication, our journey has spanned 240 partnerships across 15 countries, advancing the field of medical technology.
Our mission is to empower every client, from ambitious startups to established enterprises, with tailored solutions that bring their unique business visions to life.
Your goals are our passion, and we commit to navigating the intricate path of medical device development alongside you, ensuring the optimal outcome for every project we undertake.
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.
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.
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.
Trauma Chirurg, MST Enschede
BSN Medical | Essity
EIT, a J&J company
Belfry Medical GmbH