KOMMENDETRÆNINGER
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.
09-13.11.20205x3h online
Cybersecurity for Medical Devices
This course, organized in collaboration with CertX will support you in the preparation of strategies and tools for regulatory compliance and achieving “secure by design” .
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.
Click here to consult the training description.
17.11.20201x3h online
MDSAP Fundementals
Get an overview of the Medical Device Single Audit Program guidelines and how to get prepared.
16-18.11.2020 | 3x3.5 hours online
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.
Click here to consult the training description.
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.
01-03.12.2020 | 3x3 hours online
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
Learn what are the QRS requirements when entering on the US market.
10-11.12.2020 | 2x3.5 hours online
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 CARAQAPROGRAMMER
Tre programmer i Schweiz (Yverdon-Les-Bains og Basel / Muttenz) og Belgien (Louvain-La-Neuve) er etableret som et led i at opkvalificere personer til rollen som PRRC (Person Responsible for Regulatory Compliance) i henhold til Artikel 15 i MDR/IVDR. Følg dette link for yderligere information.