Events & online seminars
JOINT EVENT WITH SWISS MEDTECH: “Update on the impact of the MRA & MDR/IVDR on Swiss Economic Operators”
PATHWAY TO THE U.S. MARKET – HOW TO PREPARE A SUCCESSFUL 510(K) FOR YOUR DEVICE 17.05./19.07./21.09./28.10./03.12.2021
ISO 14155:2020 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS UPDATE – BRIDGING THE WAY TO THE EU MDR TRAINING 09.06./09.07./22.09./20.10/17.11.2021
EU MDR 2017/745 AND IVDR 2017/746 PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE TRAINING 23.04./21.05./24.06./16.09./15.10./18.11.2021
EU IVDR 2017/746 PERFORMANCE EVALUATION TRAINING 31.05./30.06./30.08./30.09./29.10./30.11./15.12.2021
MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP) TRAINING 10.05./08.06./13.07./15.09./06.10./10.11./06.12.2021
ISO 13485/IVDR QUALITY MANAGEMENT SYSTEM (QMS) TRAINING 16.06./25.08./27.09./25.10./26.11./10.12.2021
ISO 13485/MDR QUALITY MANAGEMENT SYSTEM (QMS) TRAINING 26.05./17.06./21.07./23.09./21.10./23.11./16.12.2021
Internal and public trainings
QUNIQUE delivers in-house and public training with top international speakers and subject matter experts towards addressing the various customer needs.
Our training service includes but is not limited to:
- Medical Device Single Audit Program
- Medical Device Regulation 2017/745
- In-Vitro Diagnostic Regulation 2017/746
- EU Clinical Evaluation Requirements
- EU Post-Market Surveillance Requirements
- Person Responsible for Regulatory Compliance
- ISO 13485 Quality Management System in the medical device sector
- ISO 14155 Good Clinical Practice
QUNIQUE’s team delivers online trainings tailored to the needs of the various international organizations by using advanced technologies to ensure good exchange and education.
Our team is flexible and willing to deliver online trainings in your time zone to ensure knowledge share globally.
QUNIQUE’s team supports various public events to educate regulatory and quality professionals about different requirements and legal obligations such as but not limited to MDSAP, ISO 13485, and medical device and in-vitro diagnostic regulations.