Roles and Responsibilities in Assuretica:

Key Responsibilities
•Conduct skilled training programs on European Medical Device Regulations
and CE Marking.
•Develop structured training modules, presentations, case studies, assessments, and
practical exercises.
•Deliver training on:
EU MDR 2017/745 Medical Devices
•Overview and regulatory framework of EU MDR 2017/745
•Medical Device Classification (Class I, IIa, IIb, III)
•Classification rules under Annex VIII
•General Safety & Performance Requirements (GSPR) – Annex I
•Technical Documentation Requirements – Annex II & Annex III
•Clinical Evaluation & Clinical Investigation Requirements
•Post-Market Surveillance (PMS)
•Vigilance Reporting & FSCA Requirements
•Person Responsible for Regulatory Compliance (PRRC)
•Economic Operators:
oManufacturer
oAuthorized Representative
oImporter
oDistributor
CE Marking Process
•CE Marking pathway for medical devices
•Conformity Assessment Procedures
•Role of Notified Bodies




•Quality Management System Requirements
ISO 13485:2016 integration with EU MDR
•Declaration of Conformity preparation
•CE Technical File preparation and review
•Transition timelines and regulatory updates
Additional Regulatory Topics
•EU MDR vs MDD/AIMDD comparison
•Risk Management as per ISO 14971
•Software Medical Device requirements (IEC 62304)
•Biocompatibility requirements (ISO 10993)
•Clinical Data Requirements
•Labeling & IFU requirements
•Post-market compliance strategies
Required Skills & Experience
•Robust practical knowledge of EU MDR 2017/745 and CE Marking process.
•Experience with medical device regulatory submissions and technical documentation.
•Experience working with Notified Bodies and CE certification projects preferred.
•Ability to train specialists from medical device companies.
•Excellent communication, presentation, and training delivery skills.

📌 European Mdr & Ce Marking Regulatory Affairs Trainer New Delhi
🏢 Assuretica
📍 New Delhi