One of the important goals of medical device companies in today’s market is launching and commercialization of their products globally. This is a challenging task, considering the different regulatory requirements in different parts of the world. In addition, many countries do not have clear-cut written regulations available to conduct clinical trials and submission for regulatory approvals. Some examples of countries and their regulatory approval methods are:
USA-FDA: medical devices are classified as class I to class III. We can support the following approvals.
We provide the following consulting services:
Develop strategy for regulatory submission – CE mark, FDA, China, Japan, Australia, and Canada.
Prepare the CE mark submission documents (for class I – III; technical files and design dossier) and support submission.
Preparation of FDA regulatory submission documents (510(k), PMA, IDE, HDE etc.) and support submission
We will prepare the documents and support submissions
We will assess the documents, design verification validation tests and quality systems for readiness for regulatory submission. Provide strategy to address the gaps.
We will coordinate / conduct / obtain manufacturing site ISO 13485 certification, which is a key element to CE marking a medical device
Prepare technical file and design dossier updates
Prepare annual updates for FDA submission for class III devices
Act as your company representative during negotiation for approvals with FDA, EU notified bodies and other geographies
Prepare product design / process notification documents to different regulatory agencies and support the submission and obtain approvals