UPCOMINGTRAININGS

EN 60601-series

14-16.07.2020 | 3 mornings online

Create a general understanding of the EN 60601-series, which is the product standard series for electrical medical devices and system. Click here to consult the training description.

Internal & Supplier Audit

16.07.2020 | 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.

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.

Click here to read the training description.

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.

training horsholm

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.

training horsholm

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.

training horsholm

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.

training horsholm

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.

training horsholm

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.

training horsholm

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 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