Medical Device Technology Regulatory Affairs

Pioneering Regulatory Strategies for Seamless Global Compliance – Ensuring Your Products Meet International Standards with Precision and Expertise

At PCI Portal, we specialize in providing comprehensive regulatory affairs support for medical device technology, ensuring that your products meet all global compliance standards with precision and expertise.

MedTech (Medical Device Technology) Regulatory Affairs

Regulatory Strategies per various Global Regulatory Requirements (e.g. US FDA 21 820, NMPA, etc.) to ensure successful device classification approvals and commercialization.
Plan and prepare pre-submission including discussions with the regulatory agencies.
Clinical Trial Management.
PMA and 510(k) submission filing.