Regulatory Affairs Support

Regulatory Affairs know-how

is required under MDR:

 

Did you already read MDR article 15(1)?

This article requires: Manufacturers shall have available within their organization at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.

What does that means for micro and small enterprises?

Article 15(2): Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.

How we can support you:

Technical File

Standard tracing

Product Registration

MDR / IVDR Gap-Assessment Support

EU Authorized Representative