Mandatory Access to the European Economic Area
CE Marking is a mandatory requirement for placing regulated products on the European Union market. With the enforcement of the new Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), compliance standards have become significantly more rigorous. At QM Service Global, we provide structured regulatory guidance to ensure your products meet all essential safety, performance, and documentation requirements—enabling lawful access across 30+ European countries within the European Economic Area (EEA).
MDR & IVDR Regulatory Transition
We assist manufacturers in transitioning from the former MDD framework to the latest MDR and IVDR regulations. Our experts provide regulatory pathway analysis, gap assessments, and implementation strategies to ensure full alignment with current EU requirements.
Technical Documentation & Risk Management
Our team prepares and reviews comprehensive Technical Files and Design Dossiers in accordance with MDR/IVDR standards. We also implement ISO 14971-compliant risk management systems to identify, evaluate, and control potential product risks.
Clinical Evaluation & Notified Body Support
We compile robust Clinical Evaluation Reports (CER) and performance documentation to demonstrate product safety and effectiveness. Additionally, we provide full support during Notified Body audits and submission processes, ensuring a smooth and compliant certification journey.
