Medical Device Regulatory Publishing - FDA 510k Submission

Device registration requirements change significantly from country to country & time to time creating challenges for companies that operate in multiple markets.

For faster and risk free registration of dossiers, a comprehensive regulatory knowledge and proper interpretation of regulatory guidelines is most needed. Our global Medical Device Regulatory experts are well experienced in registrations and technical files management for regulatory authorities. Our team manages regulatory registrations of Medical devices and IVDs across USA, UK, EU and global markets.

SERVICES

MakroCare provides device and diagnostic registration and regulatory compliance expertise for International Dossier Registration in 100+ markets providing support in preparation, submission, administrative documents, technical files, dossier registration and handling query responses. Broadly:

Compilation of Pre-submission support documents and 510(k) Premarket Notifications
Preparation of Investigational Device Exemption Applications (IDEs) & Premarket Approval Applications (PMAs). Technical Files / Design Dossiers for CE Mark
Compilation and reviewing of dossiers and prior estimation of cost and time that might be necessary in the alignment of the document with the current regulations
Reviewing of your legacy dossiers to modify them for new submissions
Review and update your proposed labeling and Instructions for Use

Benefits

Our medical device regulatory experts and project managers track regulatory changes in all markets where we operate, ensuring that your premarket application meets the most up-to-date requirements globally. A single supplier tackling all the issues from pre-submission to submission.

We aim to prepare, submit and even gain approval for your product by keeping documents compliant with the regulations of the authority or notified body. Our close collaboration will result in timely approvals.