DIGITAL DIALOGUES VOL. 2

Martin Witte

Providing an understanding of the GSPRs in general and the routes available to manufacturers in order to comply with each of the requirements this session is designed to be viewed together with the other webinars on our testing day 19 May.

Alba Marina Malavé Dos Santos, Abtin Rad

In this webinar we provide information on the standardisation initiative for single fault safety in the IEC  60601 series.

Matthias Stumpe

The webinar also presents the situation regarding certification by the Federal Communications Commission (FCC). Which requirements apply to the integration of radio modules and which tests are required for market access?

Martin Witte

Providing an understanding of the GSPRs in general and the routes available to manufacturers in order to comply with each of the requirements this session is designed to be viewed together with the other webinars on our testing day 19 May.

Alba Marina Malavé Dos Santos, Abtin Rad

In this webinar we provide information on the standardisation initiative for single fault safety in the IEC  60601 series.

Matthias Stumpe

The webinar also presents the situation regarding certification by the Federal Communications Commission (FCC). Which requirements apply to the integration of radio modules and which tests are required for market access?

Wolfgang Jakobi

The webinar presents transport simulation according to ISTA 3A and introduces the testing services offered by TÜV SÜD.

Dr. Christoph D. Lindner

This webinar informs you about the requirements and the extent of chemical characterisation and the considerations concerning later performance of toxicological risk assessments.

Mahdi Abbasi

This webinar reviews the risks to patients with implants, describes the related standards and offers solutions to characterise the risks associated with medical devices in MRI environments. The MRI testing services offered by TÜV SÜD assess medical devices and their MR-labelling to ensure patients’ safety.

Wolfgang Jakobi

The webinar presents transport simulation according to ISTA 3A and introduces the testing services offered by TÜV SÜD.

Dr. Christoph D. Lindner

This webinar informs you about the requirements and the extent of chemical characterisation and the considerations concerning later performance of toxicological risk assessments.

Mahdi Abbasi

This webinar reviews the risks to patients with implants, describes the related standards and offers solutions to characterise the risks associated with medical devices in MRI environments. The MRI testing services offered by TÜV SÜD assess medical devices and their MR-labelling to ensure patients’ safety.

Andreas Stange

Participants learn about recently published guidelines and their relevance for IVD manufacturers. Finally, we share lessons learnt from the first IVDR certification projects.

Marta Carnielli

This webinar reviews the classification rules and gives an overview of the MDCG guidance document.

Dr Julian Senac

This session reviews the new requirements introduced by the IVDR. Together with our experts we will deep dive into solutions that could be used to meet these requirements and review applicable testing for such products, such as IEC 61010, cyber security testing and EMC testing.

James Hewitt

This webinar reviews and summarises the requirements set out in the regulation for CDx devices. It also discusses the draft consultation process, which outlines the key steps and interactions between Manufacturer, Notified Body and EMA in the conformity assessment of CDx devices.

Andreas Stange

Participants learn about recently published guidelines and their relevance for IVD manufacturers. Finally, we share lessons learnt from the first IVDR certification projects. 

Marta Carnielli

This webinar reviews the classification rules and gives an overview of the MDCG guidance document.

Dr Julian Senac

This session reviews the new requirements introduced by the IVDR. Together with our experts we will deep dive into solutions that could be used to meet these requirements and review applicable testing for such products, such as IEC 61010, cyber security testing and EMC testing.

James Hewitt

This webinar reviews and summarises the requirements set out in the regulation for CDx devices. It also discusses the draft consultation process, which outlines the key steps and interactions between Manufacturer, Notified Body and EMA in the conformity assessment of CDx devices.