Navigate the complex FDA regulations with ease. FDA CertPRO provides end-to-end compliance solutions for medical device manufacturers, importers, and exporters—ensuring hassle-free approvals in the U.S. and global markets.
Register with FDA
Ensuring compliance with the U.S. Food and Drug Administration (FDA) regulations is essential for medical device manufacturers aiming to market their products in the United States. At Consult CertPRO, we specialize in guiding both domestic and international companies through the intricate FDA regulatory landscape, ensuring your medical devices meet all necessary requirements for successful market entry.
With over two decades of regulatory compliance experience, our team offers a suite of services tailored to the medical device industry:
We assist in accurately registering your establishment and listing your medical devices with the FDA, a mandatory step for legal marketing in the U.S.
For devices requiring premarket clearance, we guide you through the 510(k) submission process, demonstrating substantial equivalence to legally marketed predicate devices.
For high-risk devices necessitating rigorous evaluation, we support you in preparing and submitting PMA applications, providing evidence of safety and effectiveness.
We help implement and maintain quality management systems in accordance with FDA's QSR (21 CFR Part 820), ensuring your manufacturing processes meet regulatory standards.
Our experts review your product labels and promotional materials to ensure compliance with FDA regulations, preventing potential misbranding issues.
We assist in establishing procedures for Medical Device Reporting (MDR), ensuring timely submission of adverse event reports to the FDA.
For foreign manufacturers, we provide U.S. Agent services, facilitating effective communication with the FDA and assisting with regulatory inquiries.
Any establishment involved in the production and distribution of medical devices intended for use in the United States is required to register with the FDA. This includes manufacturers, contract manufacturers, contract sterilizers, repackagers, relabelers, specification developers, reprocessors of single-use devices, remanufacturers, and initial importers.
A 510(k) submission is a premarket notification to the FDA that demonstrates a device is substantially equivalent to a legally marketed predicate device. It is required for Class II devices and some Class I devices that are not exempt from premarket notification requirements.
A 510(k) is a premarket submission demonstrating that a device is substantially equivalent to a predicate device, typically required for moderate-risk (Class II) devices. A PMA is a more stringent application submitted to the FDA to demonstrate the safety and effectiveness of high-risk (Class III) devices.
We assist in developing and implementing quality management systems that comply with the FDA's QSR requirements, including establishing procedures for design controls, production and process controls, corrective and preventive actions, and record-keeping to ensure consistent product quality and regulatory compliance.
At Consult CertPRO, we are committed to providing expert guidance and support to help you navigate FDA regulations, ensuring your medical devices achieve compliance and reach the U.S. market successfully.