UPCOMINGTRAININGS

Internal & Supplier Audit

18.10.2019 | 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.

EN 62304

29.10.2019 | 1 day

From RA impact on embedded or standalone software to design, controls and setup of documentation. This training covers 62304 QMS implementation.
Click here to consult the training description.

training horsholm

EN 62304

21.11.2019 | 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.

Impact of MDR /IVDR on QMS & TF

26.11.2019 | 1 day

Identify applicable MDR/IVDR requirements and their impact on your QMS & technical file.

Find here agenda and registration details.

MDSAP

27.11.2019 | 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.

US Regulations

28.11.2019 | 1 day

Get an overview of QSR, FDA inspections and market access with real-case examples and exercises.
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Germany Medidee training

MDR & PMS, PMCF

Autumn 2019 | 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

MDSAP

03.12.2019 | 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

EN60601-Series

10.12.2019 | 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.

MDR & PMS, PMCF

18.12.2019 | 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

CAPA

18.12.2019 | 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

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