Канал: Rianne Tooten

harmonization EC approval process

harmonization EC approval process

Registration in publicly accessible databases

Registration in publicly accessible databases

Impact of Investigator Selection on your clinical investigation and device market access

Impact of Investigator Selection on your clinical investigation and device market access

Risk Based Monitoring

Risk Based Monitoring

Clinical Quality Management

Clinical Quality Management

How is risk management related to the ISO14155?

How is risk management related to the ISO14155?

What does a serious health threat mean?

What does a serious health threat mean?

Safety reporting under MDR in The Netherlands part III

Safety reporting under MDR in The Netherlands part III

Safety reporting under MDR in NL part II

Safety reporting under MDR in NL part II

Safety reporting under MDR in The Netherlands part I

Safety reporting under MDR in The Netherlands part I

Applicability of ISO14155 to Post Market Clinical Trials

Applicability of ISO14155 to Post Market Clinical Trials

Differences and improvements MDR and directives

Differences and improvements MDR and directives

Clinical requirements under the MDR

Clinical requirements under the MDR

Key changes to regulatory application under MDR in the Netherlands

Key changes to regulatory application under MDR in the Netherlands

Impact of MDR on clinical investigations

Impact of MDR on clinical investigations

Key changes MDR

Key changes MDR

Introduction Rianne Tooten in 2 minutes

Introduction Rianne Tooten in 2 minutes