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.

Click here to read the training description.

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” .

Complete training description here

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.

Find here agenda and registration details.

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.

Find here agenda and registration details.

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.

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.