UPCOMINGTRAININGS

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.

29-30.09.20202x3h online

ISO 14155:2020 update

Discover the impacts of the Clinical Investigation of medical devices standard update and how to implement them. Click here to consult the training description.

training horsholm

05.10.2020 | 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.

training horsholm

06.10.2020 | 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.

13.10.2020 |1x3h online

MDR & Economic Operators

Distributors, Importators: How to comply with the coming MDR/IVDR?

Click here to consult the training description.

26.10.20201x3h online

Biological Risk Assessment for Medical Devices

With this training you will get an overview of how to implement BRA for your medical device.

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.

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.

training horsholm

16-17.11.2020 | 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.

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.

training horsholm

01-02.12.2020 | 2 days

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 and QSR

Learn what are the QRS requirements when entering on the US market.

training horsholm

18.12.2020 | 1 day

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.

training horsholm

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 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