Metecon Blog: Regulatory updates for medical devices and IVDs

Stay up to date on regulatory compliance with our regular blog posts!

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Textimage of MDCG Guidance Document 2022-21: These are the highlights - Metecon GmbH
February 2023

MDCG Guidance Document 2022-21: These are the highlights
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Textimage of New regulation of in vitro diagnostics by IvDO in Switzerland -EN- Metecon GmbH
February 2023

Switzerland: New regulation of in vitro diagnostics by IvDO
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Textimage of Post-market clinical follow-up: Your entry into the PMCF-CER cycle of MDR -EN- Metecon GmbH
January 2023

Post-Market Clinical Follow-Up: Your entry into the PMCF-CER cycle of MDR
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Textimage of Regulatory Affairs 2023: Outlook on various requirements and target markets-EN- Metecon GmbH
January 2023

Regulatory Affairs 2023: Outlook on various requirements and target markets
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Textimage of the topic State of the Art: How SOTA affects the product life cycle of medical devices and IVDs -EN- Metecon GmbH
January 2023

State of the Art: How SOTA affects the product life cycle of medical devices and IVDs
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IVD 2023: What you can expect - Metecon GmbH
December 2022

IVD 2023: Das können Sie erwarten
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Textimage of Clinical evaluation and PMCF: Update and post-market clinical follow-up - Metecon GmbH
December 2022

Klinische Bewertung und PMCF: Update und klinische Nachbeobachtung nach dem Inverkehrbringen
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Textimage of Diagnostics to accompany therapy: You should think about this with CDx - Metecon GmbH
November 2022

Therapiebegleitende Diagnostika: Daran sollten Sie bei CDx denken!
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Textimage on the topic Basics: What does quality management in medical technology mean? - Metecon GmbH
November 2022

Basics: What Does Quality Management Mean in Medical Technology?
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Textimage of Biological safety: Testing medical devices safely for hemocompatibility - Metecon GmbH
October 2022

Biologische Sicherheit: Medizinprodukte sicher auf Hämokompatibilität prüfen
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Textimage of IVDR requires update of performance evaluation - How to achieve it! - Metecon GmbH
October 2022

IVDR fordert Aktualisierung der Leistungsbewertung – So schaffen Sie das!
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Textimage of Adaptation of 21 CFR Part 820 to ISO 13485:2016: What it means for you? - Metecon GmbH
September 2022

Anpassung der 21 CFR Part 820 an die ISO 13485:2016: Was heißt das für Sie?
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Regulatory History: Blog Archive

You can find older posts in our blog archive. Please make sure that this content is up to date before using it; we are happy to help.