Date: March – May 2023
Location: Virtual
Language: English
Packages
- Price in Euro: € 1495.- for all 5 sessions
On-Demand: Contact marketing@qservegroup.com for more information
* Team members with different roles and responsibilities? No problem. We offer flexible options for your company, team, or individual experts. You can send different delegates from your company to the sessions and still qualify for the package.
Introduction
The Medical Device Regulation (MDR) requires clinical evidence to demonstrate safety and clinical performance of a medical device. Clinical data obtained through clinical evaluations and investigations is required to CE mark a device. For most devices, clinical data must also be collected when the device is on the market to maintain patient safety. The regulations and guidance documents as well as applicable standards are detailed and require careful interpretation for different types of devices.
Qserve has designed a 5- session virtual training program to assist manufacturers with all clinical challenges. You will examine the latest requirements and guidance available to ensure that you collect the right type of evidence and sufficient evidence for your medical device. You will learn about the clinical evaluation process, clinical investigations and post market clinical follow up and literature search. The different sessions will present participating organizations the opportunity to prepare their subject matter experts, thus, employees will be trained on the implementation process in their specific area of expertise.
Program
- Clinical Evaluation under the MDR
- Literature Search Design for Medical Devices
- PMCF
- Clinical Surveys
- ISO 14155 GCP
Trainers
Jasmin Hunter
Aygül Dereli Öz, MSc, PhD
Bianca Lutters