UPCOMINGTRAININGS
MDR & PMS PMCF
03.10.2019 | 1 day
Get an overview of the Medical Device Regulation (MDR) and clinical evaluation related requirements.
MDSAP
03.10.2019 | 1 day
In partnership with MedicoIndstrien. We will provide you with the MDSAP guidelines to get prepared, host and conduct regulatory audits.
UDI & LABELLING
09.10.2019 | 1 day
MDR/IVDR Requirements regarding IFU, e-IFU, labelling for Medical Devices and IVD’s. You’ll also get to know how and when to implement UDI.
Click here to consult the training description.
Internal & Supplier Audit
18.10.2019 | 1 day
Intensive day on organization & methods, execution in role plays & keys of supplier audits. Prepares for ISO 9001, 13485, 17025.
EN 62304
29.10.2019 | 1 day
From RA impact on embedded or standalone software to design, controls and setup of documentation. This training covers 62304 QMS implementation.
Click here to consult the training description.
EN 62304
21.11.2019 | 2 days
In partnership with MedicoIndustrien, This training aims to bring a complete overview of the implementation of the IEC 62304 for the development of a software as a medical device.
Click here to consult the training description.
Impact of MDR /IVDR on QMS & TF
26.11.2019 | 1 day
Identify applicable MDR/IVDR requirements and their impact on your QMS & technical file.
MDSAP
27.11.2109 | 1 day
Get an overview of MDSAP guidelines to get prepared, host and conduct regulatory audits.
US Regulations
28.11.2019 | 1 day
Get an overview of QSR, FDA inspections and market access with real-case examples and exercises.
Click here to consult the training description.
MDR & PMS, PMCF
Autumn 2019 | 1 day
Get an overview of the Medical Device Regulation (MDR) and clinical evaluation related requirements.
MDSAP
03.12.2019 | 2 days
In partnership with MedicoIndstrien. We will provide you with the MDSAP guidelines to get prepared, host and conduct regulatory audits.
EN60601-Series
10.12.2019 | 2 days
In partnership with MedicoIndstrien, create a general understanding of the EN 60601-series, which is the product standard series for electrical medical devices and system.
MDR & PMS, PMCF
18.12.2019 | 1 day
Get an overview of the Medical Device Regulation (MDR) and clinical evaluation related requirements.
Click here to consult the training description.
CAPA
18.12.2019 | 1 day
In partnership with MedicoIndustrien, get familiar with the requirements for a CAPA subsystem and the methods for effective CAPA implementation.
Find here agenda and registration details
Training Catalog
On Request
Training Catalog
Custom Training
Training Catalog
Custom Training
CAS CARAQAPROGRAMS
Three similar programs in Switzerland (Yverdon-Les-Bains and Basel / Muttenz) and Belgium (Louvain-La-Neuve) preparing the future “Person in charge for Regulatory Compliance” as per Article 15 of MDR/IVDR please follow this link