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Regulatory

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.

  • 510(k)
  • Pre-Market approval (PMA)
  • Investigational device exemptions (IDE)
  • Humanitarian device exemptions (HDE)
  • Europe: CE mark
  • Canada: Canadian Medical device License (CMDL)
  • Japan, China, Korea, India, and Latin America

We provide the following consulting services:

Regulatory submission strategy

Develop strategy for regulatory submission – CE mark, FDA, China, Japan, Australia, and Canada.

Prepare CE mark submission documents

Prepare the CE mark submission documents (for class I – III; technical files and design dossier) and support submission.

Prepare FDA submission documents

Preparation of FDA regulatory submission documents (510(k), PMA, IDE, HDE etc.) and support submission

Other regulatory submissions

We will prepare the documents and support submissions

Submission readiness assessments

We will assess the documents, design verification validation tests and quality systems for readiness for regulatory submission. Provide strategy to address the gaps.

ISO 13485 certification

We will coordinate / conduct / obtain manufacturing site ISO 13485 certification, which is a key element to CE marking a medical device

Technical file and Design dossier updates

Prepare technical file and design dossier updates

FDA annual updates

Prepare annual updates for FDA submission for class III devices

Company representatives

Act as your company representative during negotiation for approvals with FDA, EU notified bodies and other geographies

Product design and process change notification

Prepare product design / process notification documents to different regulatory agencies and support the submission and obtain approvals