Do you have a great idea for a medical device and need a partner to realize it and apply a CE mark at a notified body? Read through some challenges you will encounter developing and approving medical devices. Learn what to look out for in terms of R&D, quality and regulatory capacity in the CE certification medical devices.
BAAT is an experienced partner and expert in medical device development. We have the experience and know-how to transform your dream, idea, technology or problem into a product with manufacturing route, CE mark and supply chain management.
You find the CE mark on toys, electronics, protective clothing, and many other products sold in Europe. CE marking was introduced to support the EU’s goal of removing trade barriers within the EU. Originally, products with possible safety, health or environmental issues had to be approved by each country. Now, national legislation is harmonized into Europe-wide directives or regulations; if manufacturers guarantee both the product and testing is conform these directives, they have access to all EU countries at once. Manufacturers must put the CE mark on their products to signal they conform to the applicable European directives.
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.
Contact us todayOur 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.
Contact us todayIn 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.
Contact us todayYou 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.
Contact us todayEnsuring 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.
Contact us todayTo 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.
Contact us todayTo 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.
Contact us todayOur 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.
Contact us todayIn 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.
Contact us todayYou 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.
Contact us todayEnsuring 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.
Contact us todayTo 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.
Contact us todayDid you know that as a manufacturer, you must officially declare that your product conforms to the CE mark medical device requirements? This declaration requires technical documentation, to support your ‘case’ in that your development process, and resulting medical products, are manufactured and tested conform all regulations.
Medical devices are divided into different risk classes. For the lowest risk class manufacturers may self-certify. Meaning they themselves can draw the conclusion that the technical documentation proves conformity with the regulations and put a CE mark on it.
For medium or high-risk medical devices, conformity with the regulations cannot be done by the manufacturer; a Notified Body must assess conformity before it can be placed on the market. What is a notified body in CE marking? These are organisations designated by member states of the EU who can assess conformity with specific regulations.
Medical products can only be assessed by organisations with a notified body certification specifically for assessing medical devices. The number of the Notified Body involved in the assessment must be shown; an implant assessed by the Notified Body MedCert will show ‘CE 0482’ and shown here is an example of Dekra ‘CE 0344’ as Notified Body.
When you transform your idea into an approved medical device, you will encounter hurdles. BAAT is successfully guiding customers to overcome these hurdles since 1999. Contact us today to use this experience to navigate the intricacies of working with a notified body and CE mark medical devices.
As your full-service medical device company, we’re partners for the complete journey and are only satisfied when your medical device is CE marked and successfully treating patients.
Get your medical device CE marked and successfully treat patients.
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:
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.
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.
Waldemar Link
“The engineering services of Baat really complements our own design process, while seamlessly integrating into our existing operations.”
BSN Medical | Essity
“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.”
EIT, a J&J company
“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.”
Inspine
"Baat Medical is our reliable R&D partner in various projects. The project with EIT Cellular Titanium®️ medical development has been the cherry on the pie (so far)! Can't wait what next projects are going to bring us."
Belfry Medical GmbH
“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!”
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