Training #03

Training in post-market surveillance (PMS) and vigilance applied to medical devices

Training methods

Prerequisites

None

Target audience

People involved in :

Medical device design
Regulatory affairs and quality assurance
Anyone involved in the post-market surveillance process

Further information

Location: Face-to-face or distance learning
Date: To be defined
Duration: 1 day (7 hours)

Download the training sheet

Training content

Know the methodology for carrying out post-market surveillance (SAC) and vigilance of your medical devices according to regulation (EU) 2017/745.

Post-training evaluation questionnaire
Training satisfaction evaluation questionnaire

Each participant will be able to :

Carry out SAC and vigilance according to Regulation (EU) 2017/745
Implement a SAC and SCAC (post-marketing clinical surveillance) plan integrated into the technical file
Know the type of data to integrate
Retrieve data (incidents, customer feedback, publication)
Write a SAC and SCAC report
Write a Periodic Safety Update Report (PSUR)
Complete the forms relating to vigilance

Detailed training schedule
Digital training materials
Training evaluation questionnaires
Results of trainee learning assessment
Training certificate

Regulatory requirements for SAC and vigilance
Transitional provisions relating to the SAC and vigilance
Implementation of requirements with methodology and tools to implement SAC

Starting at €980
Price adapted to your needs, number of participants and type of training (inter / intra-company).
Contact us for a personalized quote

Teaching aids (course support presentation, extracts from standards documents, document templates, etc.)
Practical exercises, feedback, case studies based on your system