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Submission File

Welcome to our Premarket Submission File Compilation Service, where we specialize in expertly preparing and compiling submission files for both Premarket Notification 510(k) and Premarket Approval (PMA) applications. Our service is designed to streamline the complex and often daunting process of FDA submission for medical device manufacturers seeking market entry in the United States.

510(k) Submission File Compilation

Our 510(k) submission service focuses on assisting clients in demonstrating that their medical device is as safe and effective as a legally marketed device (predicate device) and does not require PMA. Our service includes:

  • Initial Consultation: Understanding your device’s classification, intended use, and identifying an appropriate predicate.
  • Document Preparation: Compiling necessary documentation, including device descriptions, technical specifications, preclinical and clinical data, labeling, and more.
  • Guidance and Review: Providing regulatory guidance, reviewing submission packets for completeness and compliance with FDA regulations before submission.
  • eCopy Preparation: Ensuring the submission is in the correct electronic format for the FDA.

PMA Submission File Compilation

Our PMA service is tailored for devices that represent a breakthrough in new technologies or for devices that cannot be cleared through the 510(k) process. This service includes:

  • Pre-Submission Strategy: Developing a comprehensive plan for your PMA submission, including identification of necessary studies and clinical trials.
  • Comprehensive Documentation: Compiling detailed technical, preclinical, and clinical study documentation required for PMA applications.
  • Regulatory Correspondence: Assisting with FDA correspondence during the review process, including submission of additional information if requested by the FDA.
  • eCopy and Modular Submissions: Preparing eCopy submissions and, if beneficial, utilizing the modular PMA submission process to streamline review times.

Why do you need this service?

We support in setting up a compliant and robust submission file that fulfills all requirements. You have already a submission file but needs an update?

We are here to help.

You have difficulties to identify which format is suitable for your product? You are not sure if your current documentation is sufficient?

Leave it with us. Our experts will guide step by step.

Your product is already on the market. Do you know which post market requirements need to be met? Don't worry. We support with the proper planning and define the most appropriate post market reporting. This ensures your submission file will stay up-to-date.

Looking for submission file assistance?

Contact us to discuss how our Premarket Submission File Compilation Service can facilitate your 510(k) or PMA application. Let's navigate the regulatory pathway together, ensuring a smooth and successful submission.

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