Services
Trainings
Events & online seminars
Events & video trainings
Click on the image below for the 2021 training brochure
INTERNAL AUDITS ACCORDING TO EU IVDR 2017/746 – upon request
INTERNATIONAL REGULATORY AFFAIRS TRAINING FOR MEDICAL REGISTRATIONS – upon request
PATHWAY TO THE U.S. MARKET – HOW TO PREPARE A SUCCESSFUL 510(K) FOR YOUR DEVICE – upon request
CLINICAL EVALUATION UNDER THE EU MDR 2017/745 – 24.09.2021 and upon request
ISO 14155:2020 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS UPDATE – BRIDGING THE WAY TO THE EU MDR TRAINING – 22.09.2021 and upon request
ECONOMIC OPERATORS’ OBLIGATIONS TRAINING – upon request
EU IVDR 2017/746 POST-MARKET SURVEILLANCE TRAINING – upon request
EU MDR 2017/745 GENERAL PUBLIC TRAINING 12.07.2021 and other dates upon request
INTERNAL AUDITS ACCORDING TO ISO 13485/MDR/ISO 19011 TRAINING – upon request
EU MDR 2017/745 POST-MARKET SURVEILLANCE TRAINING – upon request
EU MDR 2017/745 AND IVDR 2017/746 PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE TRAINING – upon request
EU IVDR 2017/746 PERFORMANCE EVALUATION TRAINING 31.05.2021 and other dates upon request
MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP) TRAINING – upon request
ISO 13485/IVDR QUALITY MANAGEMENT SYSTEM (QMS) TRAINING – upon request
ISO 13485/MDR QUALITY MANAGEMENT SYSTEM (QMS) TRAINING – upon request
EU IVDR 2017/746 GENERAL PUBLIC TRAINING – upon request
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
Seminar room
Online Trainings
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.
Video calling
External Trainings
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.
External