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FAQ Friday: Answers to your questions about US agent

We are very excited about the many FAQ Friday questions we have received in the past months. Hopefully, you appreciate our expert vlogs and the answers were helpful. 🔎 In this weeks vlog, Max van Regteren answers multiple questions about US agent.

FAQ FAQ Friday Vereinigte Staaten US Agent Service USA Video Vlog

Importing face masks into the EU? What you need to know.

Are you thinking of importing Face masks into the European Union? First, you need to know how to meet the European Regulations for Face masks, what are your challenges? And how do you ensure that the masks comply to the European Regulations?

Ergebnisse

August 07, 2020

FAQ Friday: Answers to your questions about PMCF and PSURs

In this weeks FAQ Friday vlog, Giovanni di Rienzo answers questions about PMCF and PSURs.

FAQ Friday PMCF

August 04, 2020

MDCG Guidance 2020-12

Übergangsbestimmungen für die Konsultation von Behörden zu Medizinprodukten, die als integralen Bestandteil einen Stoff enthalten, der für sich allein genommen als Arzneimittel im Sinne von Artikel 1 Nummer 2 der Richtlinie 2001/83/EG gelten würde und dessen Wirkung dem des Produkts untergeordnet ist sowie für Medizinprodukte, die unter Verwendung von übertragbarer spongiformer Enzephalopathie (TSE) anfälligem tierischen Geweben hergestellt wurden.

CE Approved Medical Device Regulations

FAQ Friday: Answers to your questions about US agent

We are very excited about the many FAQ Friday questions we have received in the past months. Hopefully, you appreciate our expert vlogs and the answers were helpful. 🔎 In this weeks vlog, Max van Regteren answers multiple questions about US agent.

FAQ FAQ Friday Vereinigte Staaten US Agent Service USA Video Vlog

Why Overall Accuracy Isn't Sufficient?

There are many changes impacting the IVD world at present, changes to regulation such as the impending implementation of the IVD Regulation in Europe and also new disease states such as SARS-Cov-2 that have been impacting all our lives.

The new ISO14155 standard for Good Clinical Practice is now published!

After many delays it now officially available: the new ISO14155 standard for clinical investigations of medical devices for human subjects — Good clinical practice . This third edition of the standard cancels and replaces the second edition from 2011.

Klinische Angelegenheiten Klinische Untersuchung ISO14155 GCP Highlights

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