Medical Device Consulting for Saint Cloud, Minnesota

Headquartered outside of Boston, MA, MEDIcept has supported domestic and international MedTech companies with their regulatory, quality, and clinical services for three decades. To successfully market medical devices in the United States, European manufacturers must comply with the unique regulatory requirements of the U.S. market, which differ significantly from the European framework. Partnering with MEDIcept, a global medical device consulting firm, will streamline this complex process by establishing a tailored regulatory strategy, managing quality compliance, and supporting clinical research.

Medical Device Consulting Services

MEDIcept provides expert guidance to European companies who seek access to the U.S. market, including acting as a U.S. agent. Our medical device consulting services for Saint Cloud, Minnesota, cover the four essential steps to help bring your device to market:

1. Device Classification and Regulatory Strategy: Our team of experts begins by determining your device’s FDA classification and regulatory requirements. As defined by Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act, this classification will dictate the necessary level of regulatory control. Devices are categorized as Class I, II, or III, with Class I subject to general controls, Class II subject to general controls and Special Controls, and Class III subject to general controls and Premarket Approval (PMA).
2. Premarket Submission Preparation: Depending on your device classification, we will assist in selecting and preparing the correct submission type. Our experience ensures that submissions are fully compliant and optimally structured.
3. Clinical Trial Management: For devices requiring clinical data, MEDIcept manages clinical development, from trial design to protocol development, site management, and data handling. Our expertise ensures that trials are efficient, and the data is robust, creating a strong foundation for FDA submission.
4. FDA Submission and Review Support: Once the submission is complete, it’s sent to the FDA for review. We will support and guide you through all interactions with FDA staff, including responding to inquiries and providing necessary clarifications to facilitate a successful review.

Support Though the Entire Journey

Regulatory compliance does not end after receiving FDA approval. Medical devices and medical device manufacturers must continue to meet FDA regulatory controls, including establishment registration and device listing, adherence to Quality System Regulations, and accurate device labeling. MEDIcept provides Saint Cloud, Minnesota area medical device consulting to MedTech companies through each step of this compliance process to ensure ongoing FDA approval.

MEDIcept works with medical device companies in Paris, France to succeed in the highly competitive and evolving U.S. market. With over three decades of experience, MEDIcept provides European manufacturers with expert and knowledgeable guidance.

To learn more about MEDIcept’s medical device consulting services and how we can support your journey to U.S. market access, contact us today at sales@medicept.com.