Regulatory Compliance
MDR / IVDR TF preparation
AI and M/L compliance
Subject matter expert review
Clinical investigation
Clinical evaluation
PSUR
PMCF preparation
Biocompatibility
Risk management file
Usability engineering
Other domain Compliance
Egypt [EDA Application and approvals]
Saudi Arabia [file preparation according to SFDA MDMA 1/2]
EU MDR/ IVDR Compliance
Our comprehensive suite of services designed to assist your organization in achieving and maintaining compliance with the European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), as well as navigating the evolving regulatory landscape surrounding artificial intelligence (AI) and machine learning (M/L) in medical devices.
Our expertise includes the meticulous preparation of technical files (TF) essential for MDR/IVDR compliance, ensuring that your documentation meets the stringent requirements set forth by European regulatory bodies. We provide subject matter expert reviews to thoroughly examine your files, guaranteeing adherence to current standards and mitigating the risk of non-compliance.
Our services extend to biocompatibility testing, ensuring that your devices are safe for patient use, alongside the development and maintenance of detailed risk management files to systematically identify and control potential hazards. To complement these efforts, our usability engineering expertise ensures that your devices are not only compliant but also user-friendly, enhancing overall patient and healthcare provider experience.
Furthermore, recognizing the increasing integration of AI and M/L in medical devices, we guide you through the complex regulatory requirements specific to these advanced technologies, assuring that your innovative products meet all necessary compliance benchmarks.
We are confident that our thorough and tailored approach will provide significant value in your regulatory affairs, helping to streamline your product development and approval process within the EU market.
FDA Compliance
QS Experts proud to show our comprehensive suite of services specifically tailored to assist your medical device business in successfully navigating the complex and ever-evolving landscape of FDA regulatory requirements. Our mission is to simplify and streamline regulatory processes so you can focus more on innovation and business growth while ensuring full compliance.
Establishment registration & Device Listing.
These mandatory FDA filings are critical for market entry and ongoing compliance. Our experienced team handles these filings with precision and efficiency, reducing the administrative burden on your organization and minimizing the risk of errors or delays. By entrusting these tasks to us, you can be confident that all statutory obligations are met promptly and correctly.
PMA / 510k review service
These mandatory FDA filings are critical for market entry and ongoing compliance. Our experienced team handles these filings with precision and efficiency, reducing the administrative burden on your organization and minimizing the risk of errors or delays. By entrusting these tasks to us, you can be confident that all statutory obligations are met promptly and correctly.
act as your Official US Agent.
This service is essential for all foreign medical device manufacturers seeking to do business in the United States. We represent your company to the FDA and other US regulatory bodies, ensuring seamless communication and adherence to US-based operational requirements. Our local presence mitigates geographical and regulatory challenges, facilitating smoother interactions with regulatory authorities.
Official Correspondent
QS Experts ease your burden by serving as your Official Correspondent. We expertly manage everything from new registrations and updates to deactivations, ensuring your devices consistently meet compliance standards throughout the year. Trust us to handle the complexities.
Device classification
Correct device classification is vital in determining the appropriate regulatory pathway and compliance strategy. Our Device Classification Support involves careful evaluation and accurate determination of your medical device’s FDA classification. This expertise ensures that you submit the correct documentation, comply with relevant regulations, and avoid costly delays or rejections.
UDI and GUDID Set-Up
UDI and GUDID Set-Up and Submissions service simplifies the entire process. We assist in the proper assignment of Unique Device Identifiers, manage database submissions to the Global Unique Device Identification Database (GUDID), and ensure compliance with FDA mandates. This not only supports product traceability but also enhances patient safety and supply chain management.
eMDR (electronic Medical Device Reporting)
eMDR (electronic Medical Device Reporting) service designed to streamline the submission of adverse event reports electronically. This service improves reporting accuracy, timely compliance with FDA requirements, and helps manage post-market surveillance effectively
Conflict resolution
warning letter and detentions can severely impact your business operations and market reputation. Our Assistance is dedicated to helping you quickly resolve compliance issues, working closely with FDA officials to address concerns, provide necessary documentation, and achieve satisfactory resolutions. Our proactive approach minimizes downtime and potential financial losses.
Get Started with us today
QS Experts offer a wide range of services Whether you’re launching a new product or expanding internationally