UPCOMINGTRAININGS
EN 62304
May 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.
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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
27.11.2019 | 0,5 day (PM)
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.
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MDR Auditing
28.11.2019 | 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.
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.
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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.
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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