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Faits marquants

janvier 22, 2021

FAQ Friday with Giovanni: answers to your questions about vigilance and incident reporting

In this weeks vlog, Giovanni answers the question: Does it mean that if a certain type of serious incident has been listed in the IFU and assessed in the risk management as acceptable, then it is not to be reported? Even if it has a causal relationship with the device?

FAQ Friday MDR 2017/745 Medical Device Regulations

janvier 31, 2020

EU-MDR and EU-IVDR Booklets for sale in two convenient sizes

The Qserve MDR and IVDR in two convenient sizes: one for on your desk and one for in your bag.

Europe Medical Device Regulations IVDR Qserve Group

Résultats

janvier 22, 2021

FAQ Friday with Giovanni: answers to your questions about vigilance and incident reporting

In this weeks vlog, Giovanni answers the question: Does it mean that if a certain type of serious incident has been listed in the IFU and assessed in the risk management as acceptable, then it is not to be reported? Even if it has a causal relationship with the device?

FAQ Friday MDR 2017/745 Medical Device Regulations

janvier 21, 2021

On Demand Webinar | Risk Management Under the MDR with Keith Morel

MDR 2017/745 Regulatory Affairs Regulatory Compliance Risk Management

janvier 21, 2021

On- Demand Webinar | Risk Management Under MDR with Keith Morel

MDR 2017/745 Regulatory Affairs Regulatory Compliance Risk Management

janvier 18, 2021

MDR remote audits – Some good news but…

Not often in the past few years we have started a week with good news from the EU Commission but, much to our surprise, last week was one of those.

Medical Device Regulations

janvier 13, 2021

Top 10 Questions regarding the UK Responsible Person and medical device/IVD registration with the MHRA

An overview of the top 10 questions regarding the UK Responsible Person & medical device and IVD registration with the MHRA.

MHRA UK Responsible Person UKCA

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