CE Mark for Medical Devices

To ensure a successful collaboration, we strive to understand your goals and business opportunities and get clear how our services fit best in your journey. With our 20+ years of experience we understand the dynamics of getting an idea to the medical device market. We will help you formulate the right strategy for device development, manufacturing, regulatory affairs, safety questions, clinical trials and legal obligations to get your medical device approved in the EU and US. Together we define and refine the crucial steps to reach your milestones.

Our competent BAAT team will develop your product and manufacturing process and provide all documentation needed to get market approval. We have learned that development of a medical device is a dynamic process, that never follows a straight line from start to finish. We will provide you with the right input to decide on next steps in the process. This allows us to achieve the best results possible within the time and budget restrictions you have set.

In order for you to understand the supply chain needs, you’ll want to get curious about the complicated puzzle that is medical manufacturing. Get to control, trace and monitor all aspects you will encounter from production, packaging, sterilizing, storing, transport and inspection by outsourcing your supply chain and leveraging our network of trusted and verified suppliers. We let you be the master of logistics and supply and ensure all control and safety in the medical supply network.

You probably know that regulatory affairs is an important piece of your medical devices puzzle. Which rules apply for your project in order to get approval from FDA and MDR? You want to be fully covered and know about existing and upcoming changes in regulations. Be smart and do not go reinventing the wheel. Instead make use of our proved ISO 13485 certified Quality Management System. This system is specially built to assure compliance from approval throughout the complete lifecycle of your product. We designed our QMS to ensure a fluent transfer and be linked to you own processes easily.

Ensuring Clinical Safety and Performance is paramount when developing and marketing a medical device, especially for the European market. We concentrate all our activities around one question: Does the expected benefit of your device, when following the intended use, outweigh the inherent risks? Our Clinical Specialists know how to answer this question in the most efficient way. They navigate this delicate process, define the optimal route for collection of Clinical Data to get market approval and to access clinical safety and performance throughout the complete lifecycle of your product.

To bring your innovation to the market include various legal liability issues, associated with being a (legal) ‘manufacturer’ as is directed by the MDR and FDA regulations. This has nothing to do with intellectual property, branding or ownership; it is the formal legal responsibility, that is directly linked with the entity that develops, manufactures and delivers a medical device for use to the market. At BAAT we know what it means to bear this responsibility because we are able to formally act as legal manufacturer on behalf of our customers. We can help you to identify and solve liability issues throughout the manufacturing chain, put the right insurance coverage in place and make sure that all quality agreements are properly connected.