KOMMENDETRÆNINGER
Cybersecurity
31.08 - 04.09.2020 |5 days online
In partnership with CertX, we have developed 5 modules linking key regulatory and technical consideration related to developing medical device software, with a specific focus on cybersecurity requirements.
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.
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.
October 2020 |2x2h online
MDR & Economic Operators
Distributors, Importators: How to comply with the coming MDR/IVDR?
Click here to consult the training description.
06.10.2020 | 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.
Internal & Supplier Audit
Autumn 2020 | 1 day
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.
16.11.2020 | 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.
Click here to consult the training description.
EN 60601-series
01.12.2020 | 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.
MDSAP
08.12.2020 | 2 days
In partnership with MedicoIndstrien. We will provide you with the MDSAP guidelines to get prepared, host and conduct regulatory audits.
CAPA
18.12.2020 | 1 day
In partnership with MedicoIndstrien. Get familiar with the requirements for a CAPA subsystem and the methods for effective CAPA implementation.
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.