UPCOMINGTRAININGS

24.03.2020 | 1 day

CER, PMS and PMCF within the MDR

[online training] Get an overview of the Medical Device Regulation (MDR) and clinical evaluation related requirements. Click here to consult the training description.

28.04.2020 | 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.

30.04.2020 | 1 day

Risk Management

Understand the application of ISO14971 Risk Management, specifically to medical devices. Click here to consult the training description.

training horsholm

EN 62304

18.05.2020 | 2 days

In partnership with MedicoIndustrien, 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

EN60601-Series

03.06.2020 | 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

CAPA

15.06.2020 | 1 day

In partnership with MedicoIndustrien, get familiar with the requirements for a CAPA subsystem and the methods for effective CAPA implementation.
Find here agenda and registration details

MDSAP

Summer 2020 | 0,5 day (PM)

Get an overview of MDSAP guidelines to get prepared, host and conduct regulatory audits.

Click here to consult the training description.

Germany Medidee training, Medidee medical services

MDR & CER, PMS

Summer 2020 | 1 day

Get an overview of the Medical Device Regulation (MDR) and clinical evaluation related requirements.

Click here to consult the training description.

training horsholm

MDR Auditing

Summer 2020 | 1 day

In partnership with MedicoIndstrien. Gain knowledge about the MDR requirements not covered by ISO 13485 and understand the MDR requirements related to the QMS and their impact.

Find here agenda and registration details.

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.

training horsholm

Autumn 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.

Belgium Medidee training, Medidee medical services

Autumn 2020 | 1 day

MDR & CER, PMS

Get an overview of the Medical Device Regulation (MDR) and clinical evaluation related requirements.
Click here to consult the training description.

training horsholm

MDSAP

Summer 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.

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.

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