UPCOMINGTRAININGS
04.09.2020 | 1 day
Training of Internal Auditors in Relation to MDR
Understand the MDR requirements related to the QMS and their impact. Learn what to look for when auditing a QMS against the MDR requirements
Click here to consult the training description.
29-30.09.20202x3h online
ISO 14155:2020 update
Discover the impacts of the Clinical Investigation of medical devices standard update and how to implement them. Click here to consult the training description.
05.10.2020 | 1 day
Internal auditors training & MDSAP program
Training of internal auditors in relation to country specific requirements within the MDSAP program
Click here to consult the training description.
06.10.2020 | 1 day
Training of Internal Auditors in Relation to MDR
Understand the MDR requirements related to the QMS and their impact. Learn what to look for when auditing a QMS against the MDR requirements
Click here to consult the training description.
13.10.2020 |1x3h online
MDR & Economic Operators
Distributors, Importators: How to comply with the coming MDR/IVDR?
26.10.20201x3h online
Biological Risk Assessment for Medical Devices
With this training you will get an overview of how to implement BRA for your medical device.
03-04.11.20202x3h online
Risk Management
This Risk Management training will bring you the key elements to perform an efficient Risk Analysis for your Medical Device / IVD.
09-11.11.20202x3h online
MDR: CER, PMS, PMCF
With this training you will get an overview of the Medical Device Regulation (MDR) and clinical evaluation related requirements
12.11.2020 | 1 day
Internal & Supplier Audit
Intensive day on organization & methods, execution in role plays & keys of supplier audits. Prepares for ISO 9001, 13485, 17025.
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17.11.20201x3h online
MDSAP Fundementals
Get an overview of the Medical Device Single Audit Program guidelines and how to get prepared.
16-17.11.2020 | 2 days
IEC 62304 Software Lifecycle
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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26-27.11.20202x3h online
Road to IVDR Compliance
Learn and get the tools either to ensure your transition from IVDD to IVDR or to understand the requirements and place your device on the market ready with the IVDR.
01-02.12.2020 | 2 days
EN 60601-series
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.
10-11.12.20202x3h online
US Regulations and QSR
Learn what are the QRS requirements when entering on the US market.
18.12.2020 | 1 day
CAPA
In partnership with MedicoIndstrien. Get familiar with the requirements for a CAPA subsystem and the methods for effective CAPA implementation.
08.12.20201x3h online
PRRC function for MD and IVD
With this training you will learn how to install the PRRC function in your company.
08.12.2020 | 2 days
MDSAP Fundamentals
In partnership with MedicoIndstrien. We will provide you with the MDSAP guidelines to get prepared, host and conduct regulatory audits.
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