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 partner in expert medical device design engineering. BAAT has 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 Device Engineering expertise at your Fingertips
Medical device engineering is applying engineering principles for healthcare purposes. It is not just calculations, drawings and tolerances; it is about creating a meaningful impact on the lives of patients. During the journey from idea to product there are important questions to answer, many of them not of technical nature:
- What concept works for all users (patient, OR assistant, surgeon, etc.)?
- How can all users safely and effectively use the medical device (human factors engineering medical devices
- How can the design, production process and packaging be fully specified?
- Who can work together to make it?
More Engineering challenges and asking the right questions
Asking the right questions is the first step to a successful project. Having impact on the end user means impact in the market. Some examples:
- How can we prove safety and performance for the patient and other users (human factors engineering medical devices)?
- 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? This is another example of human factors engineering medical devices.
One of the steps many customers do is answering above questions using an Innovation Scan. We call it ‘Innoscan’. Get in contact with Baat to see what can lead to a commercially viable product development and real impact in the medical device business.
It’s all about 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.
ISO 13485 Certification
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+ people with various fields of expertise, our expertise with medical device engineering for both the EU and US markets with 30+ products developed (projects), but also of our underlying quality system.
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Our Customers About Us
“Successful products are not made only of great ideas; they require a good understanding of todays and tomorrows market environment. The INNOVATE process was very insightful. It helped us define and decide what is necessary to fulfil all stakeholders’ present and future requirements in order to have a high impact product and treatment. BAAT did a great job!”Pablo EnriquezBelfry Medical GmbH
“Thanks to the close collaboration of our engineers with the BAAT team, we could execute our development strategy as planned. We couldn’t have reached this level of success without them.”Guntmar EisenEIT, a J&J company
“Baat heeft gezorgd dat mijn idee werkelijkheid is geworden. Het draagt nu echt bij aan betere zorg voor de patient, en aan het gemak van chirurgen. Geweldig om samen te werken aan het realiseren van een innovatie. Ik kan Baat 100% aanbevelen aan chirurgen en ziekenhuizen die echt stappen willen maken.”Ariaan D.P. van WalsumTrauma Chirurg, MST Enschede
“The engineering services of Baat really complements our own design process, while seamlessly integrating into our existing operations.”Dr. Hans-Joachim FischerWaldemar Link
“Thanks to everyone at Baat medical involved in this project. We are very satisfied with your service (including performance, communication, and flexibility) and are looking forward to possible new collaborations.”Dr. Oliver HassBSN Medical
“I appreciate to work together with you and your company. At the end I’m happy with the outcome and I’m looking forward to the market launch.Katharina BarschSilony Medical
I appreciate the support of you and your company with a lot of experience. Many thanks to you and your team.
I would be happy to start a new project in future together with you and I’m looking forward to our cooperation during market phase.”
Medical Device Engineering Companies
When you transform your idea into a medical device you will encounter many hurdles. BAAT has created many medical devices for a broad range of customers since 1999. From the medical device engineering companies, we are your go-to expert with our highly skilled team and extensive experience. Use our experience to navigate the intricacies of developing your product and getting it approved for market introduction.What makes us truly unique as a medical device engineering company:
- 25+ experts on all disciplines
- 30+ products to market
- Both EU and US markets product launches
- Quality management system
Discover your own potential and focus on entrepreneurship by outsourcing medical product engineering versus investing in organizing all activities, responsibilities and a quality management system in house.