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.
How to make real world impact with your medical device
Transforming a medical device idea into a market success requires a clear, actionable strategy. We offer end-to-end support to not only develop your product but also launch and scale it effectively. Our strategic expertise covers areas like:
• Market Research & Market Entry
• Business Case Development
• Key Industry Connections
Why choose us to shape your strategy?
We manage every step — from crafting your strategy, developing your product, streamlining manufacturing and ensuring ongoing compliance. With BAAT, your vision doesn’t just take shape – it thrives.
How to turn your vision into reality
Turning a medical device concept into a tangible, market-ready product takes knowledge and experience. Our comprehensive development services guide you from initial idea to market-ready product, ensuring every detail aligns with your vision. Our development service includes critical areas like:
• Concept Development
• Needs & Requirements
• Usability
• Prototyping
• Industrial Design
• Verification & validation testing
• Risk Management
• Intellectual Property
• Packaging & Labelling
• eIFU (Electronic Instructions for Use)
• Project Management
Why Develop your medical device with us?
We get your vision into reality with our proven process—covering everything from innovative design to regulatory-compliant solutions. With our support, your product doesn’t just get built — it stands out.
How to craft your medical device with precision
Turning your medical device concept into reality requires more than just equipment—it demands a robust, efficient process. Our manufacturing services focus on building your product at scale, ensuring quality and readiness for market approval. We handle critical elements like:
• Design for Manufacturing
• Supplier Selection & Evaluation
• Selecting a Legal Manufacturer
• Production Process Development
• Material Sourcing & Supply Chain Setup
• Prototype-to-Production Transition
Why choose us for Manufacturing?
We optimize every stage—from refining your design for production to selecting reliable suppliers—ensuring your device is built with precision and efficiency. Your vision isn’t just produced; it’s perfected for the next step.
How to navigate the regulatory maze with confidence
Getting your medical device approved and compliant is complex — but it doesn’t have to be daunting. Our regulatory affairs expertise clears the path to market entry. We handle essential aspects like:
• MDR CE certification
• FDA Listing
• Regulatory Strategy
• Regulatory Submission
• PRRC (Person Responsible for Regulatory Compliance)
• Compliance Remediation
Why choose us for Regulatory Affairs?
We simplify complexity, aligning your medical device with global regulations and accelerating approvals. With our guidance, compliance becomes a strength, not a hurdle.
How to prove your device delivers
Demonstrating safety and efficacy is critical to your medical device’s success. Our clinical evaluation services provide the evidence you need to stand out. We cover vital areas like:
• Clinical Strategy
• Clinical Trials
• PMCF (Post-Market Clinical Follow-Up)
• PMS & Vigilance (Post-Market Surveillance)
• PSUR (Periodic Safety Update Reports)
• KOLs (Key Opinion Leaders)
Why choose us for Clinical Evaluation?
We design and execute lean evaluations that meet regulatory demands and build trust — turning data into your competitive edge. Your device doesn’t just perform; it proves itself.
How to make real world impact with your medical device
Transforming a medical device idea into a market success requires a clear, actionable strategy. We offer end-to-end support to not only develop your product but also launch and scale it effectively. Our strategic expertise covers areas like:
• Market Research & Market Entry
• Business Case Development
• Key Industry Connections
Why choose us to shape your strategy?
We manage every step — from crafting your strategy, developing your product, streamlining manufacturing and ensuring ongoing compliance. With BAAT, your vision doesn’t just take shape – it thrives.
How to turn your vision into reality
Turning a medical device concept into a tangible, market-ready product takes knowledge and experience. Our comprehensive development services guide you from initial idea to market-ready product, ensuring every detail aligns with your vision. Our development service includes critical areas like:
• Concept Development
• Needs & Requirements
• Usability
• Prototyping
• Industrial Design
• Verification & validation testing
• Risk Management
• Intellectual Property
• Packaging & Labelling
• eIFU (Electronic Instructions for Use)
• Project Management
Why Develop your medical device with us?
We get your vision into reality with our proven process—covering everything from innovative design to regulatory-compliant solutions. With our support, your product doesn’t just get built — it stands out.
How to craft your medical device with precision
Turning your medical device concept into reality requires more than just equipment—it demands a robust, efficient process. Our manufacturing services focus on building your product at scale, ensuring quality and readiness for market approval. We handle critical elements like:
• Design for Manufacturing
• Supplier Selection & Evaluation
• Selecting a Legal Manufacturer
• Production Process Development
• Material Sourcing & Supply Chain Setup
• Prototype-to-Production Transition
Why choose us for Manufacturing?
We optimize every stage—from refining your design for production to selecting reliable suppliers—ensuring your device is built with precision and efficiency. Your vision isn’t just produced; it’s perfected for the next step.
How to navigate the regulatory maze with confidence
Getting your medical device approved and compliant is complex — but it doesn’t have to be daunting. Our regulatory affairs expertise clears the path to market entry. We handle essential aspects like:
• MDR CE certification
• FDA Listing
• Regulatory Strategy
• Regulatory Submission
• PRRC (Person Responsible for Regulatory Compliance)
• Compliance Remediation
Why choose us for Regulatory Affairs?
We simplify complexity, aligning your medical device with global regulations and accelerating approvals. With our guidance, compliance becomes a strength, not a hurdle.
How to prove your device delivers
Demonstrating safety and efficacy is critical to your medical device’s success. Our clinical evaluation services provide the evidence you need to stand out. We cover vital areas like:
• Clinical Strategy
• Clinical Trials
• PMCF (Post-Market Clinical Follow-Up)
• PMS & Vigilance (Post-Market Surveillance)
• PSUR (Periodic Safety Update Reports)
• KOLs (Key Opinion Leaders)
Why choose us for Clinical Evaluation?
We design and execute lean evaluations that meet regulatory demands and build trust — turning data into your competitive edge. Your device doesn’t just perform; it proves itself.
Did 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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