Medical Device Consulting
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 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 design consultancy or partnership?
During the journey from idea to product there are important topics to address, each with their own flavor of “Medical Device Consultants Inc.”: design consultants, development consultants, strategy consultants, regulatory consultants, reimbursement consultants, quality consultants. Is that what you actually need? Or do you want to collaborate confidently with one partner who has it all under control? As your full-service partner we’re not just about delivering medical device regulatory consulting, a drawing or report; we care about creating a meaningful impact on the lives of patients.
Call our New Business Developer (Dymphy) now:+31885656600
Medical devices: it’s all about the system
Even the most experienced people from top medical device consulting firms 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 expert consultants is not enough; they must use a thorough 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.
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. This makes BAAT an excellent partner to completely outsource medical device development versus outsourcing individual topics to specific medical device consulting companies, while still investing in organizing responsibilities and quality management system in house.
When you transform your idea into a medical device you will encounter hurdles. BAAT has created many medical devices for a range of customers since 1999. Use our experience to navigate the intricacies of developing your product and getting it approved for market introduction.
Contact us to reach your goals
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.