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.

Find here agenda and registration details.

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.

Find here agenda and registration details.

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.

Find here agenda and registration details.

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.

Find here agenda and registration details.

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.