Your Pathway to Market Approval

Expert Guidance on Product Registration

Navigating the regulatory landscape for medical devices and IVD products can be complex and daunting. At confinis, we specialize in creating and managing comprehensive technical documentation and submission files needed for CE marking, FDA approvals, and other global regulatory submissions. Our deep expertise ensures that your product meets all necessary regulatory requirements efficiently.

Choosing the Right Conformity Assessment Route

Choosing the correct pathway for CE marking under IVDR compliance is crucial. Once the device’s risk class is defined, manufacturers must adhere to specific conformity assessment routes outlined in the Annexes IX to XI of the IVDR. These routes vary based on the risk class of the product, and selecting the correct one is vital to ensure compliance and facilitate market entry.

Streamlined Submissions and Interactions

Our consultants are adept at managing regulatory submissions and maintaining productive interactions with notified bodies and regulatory agencies worldwide. Whether you are navigating the complexities of the FDA process in the United States or tackling CE marking in Europe, confinis provides strategic support every step of the way.

Why Efficient Regulatory Navigation is Critical

Efficient and accurate regulatory navigation is not just about compliance—it’s about getting your product to market faster and more cost-effectively. With the right regulatory support and expertise, you can significantly reduce the time and expense involved in obtaining necessary certifications and approvals.

Our Mission

At confinis, our mission is clear: to help you bring your product to market as quickly and cost-effectively as possible. By leveraging our extensive experience and proactive approach, we ensure that your product does not just meet regulatory standards but excels, paving the way for successful market entry and commercial success.