UPCOMINGTRAININGS
CAPA
03.02.2020 | 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
Impact of MDR /IVDR on QMS & TF
05.03.2020 | 1 day
Identify applicable MDR/IVDR requirements and their impact on your QMS & technical file.
MDR & PMS, PMCF
Spring 2020 | 1 day
Get an overview of the Medical Device Regulation (MDR) and clinical evaluation related requirements.
Click here to consult the training description.
MDR Auditing
Spring 2020 | 1 day
In partnership with MedicoIndstrien. Gain knowledge about the MDR requirements not covered by ISO 13485 and understand the MDR requirements related to the QMS and their impact.
EN 62304
18.05.2020 | 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.
MDSAP
Spring 2020 | 0,5 day (PM)
Get an overview of MDSAP guidelines to get prepared, host and conduct regulatory audits.
MDR & PMS, PMCF
Spring 2020 | 1 day
Get an overview of the Medical Device Regulation (MDR) and clinical evaluation related requirements.
EN60601-Series
03.06.2020 | 1 day
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.
MDSAP
Summer 2020 | 2 days
In partnership with MedicoIndstrien. We will provide you with the MDSAP guidelines to get prepared, host and conduct regulatory audits.
US Regulations
Summer 2020 | 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.
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