Predict the future of medical device industry with Molgenium
ISO 13485 & MDR Compliance
Phase 1: Pre-Assessment & Gap Analysis
Understand Regulatory Requirements
Study ISO 13485:2016 and EU MDR (2017/745).
Identify applicable regulatory pathways (e.g., CE Marking classification).
Determine product-specific requirements, including risk classification.
Perform a Gap Analysis
Compare existing processes with ISO 13485 & MDR requirements.
Identify missing procedures, documentation gaps, and compliance deficiencies.
Develop an action plan for implementation.
Engage Key Stakeholders
Appoint a Regulatory Compliance Manager or hire an external consultant.
Define roles and responsibilities for quality, regulatory, production, and clinical teams
Phase 2: Establishing the Quality Management System (QMS)
Develop Quality Documentation
Create a Quality Manual outlining QMS scope and policies.
Implement Standard Operating Procedures (SOPs) for key processes:
Design & Development
Risk Management (ISO 14971)
Supplier & Vendor Controls
Manufacturing & Process Validation
Complaint Handling & CAPA (Corrective and Preventive Actions)
Post-Market Surveillance (PMS) & Vigilance
Implement Risk Management
Develop a Risk Management Plan aligned with ISO 14971.
Perform Failure Modes and Effects Analysis (FMEA) for design and production risks.
Design & Development Controls
Establish Design History File (DHF) and Technical Documentation.
Implement Usability Engineering (per IEC 62366).
Conduct Clinical Evaluation (MDR Annex XIV) and Biocompatibility Studies (ISO 10993) if required.
Supplier & Production Control
Implement supplier qualification and vendor audits.
Ensure traceability of raw materials and components.
Validate manufacturing processes and equipment.
Establish Training Programs
Train employees on ISO 13485 requirements and MDR compliance.
Conduct regular refresher sessions on SOPs and regulatory updates.
Phase 3: Internal Audits & Certification Preparation
Conduct Internal Audits
Develop an audit schedule for all processes.
Evaluate compliance with ISO 13485 & MDR through mock audits.
Document findings and implement CAPA to address non-conformities.
Compile Technical Documentation & Submit for Notified Body Review
Prepare the Technical File (Annex II, MDR) for CE Marking.
Submit the Quality System documentation for Notified Body (NB) assessment.
Undergo External Audit & Achieve Certification
Respond to NB audit findings and implement corrective actions.
Obtain ISO 13485 certification and CE Mark approval for medical devices.
Phase 4: Post-Market Surveillance & Continuous Improvement
Post-Market Surveillance (PMS) & Vigilance System
Implement a PMS Plan (Annex III, MDR) for continuous monitoring.
Establish a vigilance system for reporting serious incidents to regulatory authorities.
Conduct Periodic Safety Update Reports (PSURs) for Class IIa, IIb, and III devices.
Maintain Regulatory Compliance
Stay updated with MDR amendments & Notified Body requirements.
Continuously improve QMS based on audit findings and performance data.
