HUKSA https://validator.w3.org/feed/docs/rss2.html Hospital Billing and EHR Systems: Pharma Operations Conformity Assessment & CE Marking Traceability, Transparency & EUDAMED Unique Device Identification (UDI) system implementation Device registration and data submission to EUDAMED Responsibilities of economic operators for traceability Labeling and product identification requirements Transparency obligations and public access to safety information Post-Market Surveillance & Vigilance Post-Market Surveillance (PMS) system requirements Vigilance reporting and incident notification timelines Periodic Safety Update Reports (PSUR) and trend reporting Field Safety Corrective Actions (FSCA) and recall management Continuous lifecycle monitoring of device safety and performance Strategic Market Readiness for EU Launch Building MDR-compliant regulatory strategy for product launch Aligning R&D, quality, and regulatory teams for compliance Managing global regulatory differences (EU vs US vs other markets) Preparing organizations for MDR audits and inspections Developing long-term regulatory compliance roadmaps EU MDR Compliance & Market Access Strategy for Medical Devices EU Medical Device Regulation Landscape Evolution from MDD/AIMDD to MDR (EU 2017/745) Key regulatory objectives: safety, transparency, lifecycle oversight Scope expansion including software and digital medical devices Regulatory bodies: European Commission, Competent Authorities, Notified Bodies Current MDR transition timelines and global implications Device Classification and Regulatory Pathways MDR classification rules (Class I, IIa, IIb, III) Determining regulatory strategy based on risk classification Role of economic operators: manufacturer, importer, distributor, authorized representative Person Responsible for Regulatory Compliance (PRRC) requirements Market access pathways for EU manufacturers and non-EU companies Quality Systems & Technical Documentation General Safety and Performance Requirements (GSPRs) under MDR Technical documentation structure and technical file requirements Risk management and design control integration Quality Management Systems aligned with ISO 13485 Labeling, instructions for use, and regulatory documentation standards Clinical Evaluation & Clinical Investigation Clinical evidence requirements under MDR Clinical Evaluation Reports (CER) and literature review methods Clinical investigations for high-risk devices Post-Market Clinical Follow-up (PMCF) strategy Role of clinical data in demonstrating safety and performance Conformity assessment procedures for different device classes Notified Body audits and certification requirements Preparing for technical documentation review and QMS audits Declaration of Conformity and CE marking process Home Main