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RAMS®

Eine Plattform mit digitalen Produkten zum Verbessern, Vereinfachen und Automatisieren von QS/RA-Abläufen.

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OPUS™

Neues Human-Factor-Tool von Emergo by UL – bietet Schulungen, Tools und Ressourcen.

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Unsere Software-Tools bieten eine digitale Überwachung der Einhaltung von Vorschriften für Medizinprodukte und Zugang zu Human-Factors-Engineering-Tools.

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Die neuesten Brancheninformationen und -einblicke von unserem internationalen Team.

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RADAR : Market Access Newsletter

Bleiben Sie immer auf dem Laufenden mit dem meistgelesenen RA/QA-Newsletter für Medizinprodukte.

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TalkingPoints ist eine Zusammenstellung von Nachrichten, Erkenntnissen und Ressourcen über Human Factors und Benutzerfreundlichkeit bei medizinischen Geräten, IVDs, Kombinationsprodukten und mehr.

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Regulatorische Updates

Bleiben Sie stets über die neuesten regulatorischen Änderungen auf dem Laufenden.

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  • Regulatory Update
Jan 5 , 2021

UK MHRA Issues Post-Brexit Medical Device, IVD Registration Requirements

UK regulators clarify post-Brexit registration requirements and deadlines for medical devices, IVDs and related healthcare products. Learn more about UK medical device and IVD regulations at Emergo by UL.
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  • Regulatory Update
Dec 17 , 2020

Cold Chain Management for COVID-19 Vaccines: Ensuring Safe and Effective Distribution

What pharmaceutical, medical device and other manufacturers should consider as vaccine cold chain processes evolve.
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  • Regulatory Update
Dec 2 , 2020

Eudamed Actor Module FAQ Now Live

The main reason for an economic operator to register in Eudamed has to do with the Single Registration Number (SRN).
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  • Regulatory Update
Nov 4 , 2020

MDSAP Council Updates Guidance on Conformity Assessments and Related Requirements

The participating regulators in the medical device single audit program (MDSAP) issued a new guidance documents that is consolidated from two existing documents and expanded with additional annexes.
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  • Regulatory Update
Sep 30 , 2020

An Assessment of the Proposed Rule to Change US FDA’s Interpretation of Intended Use

Analysis of FDA's proposed new definition of Intended Use concepts pertaining to medical devices and drugs, and recommendations for how manufacturers can prepare for possible changes.
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  • Regulatory Update
Sep 29 , 2020

2020 Amendments to IEC 62366 – Implications for Medical Device Usability Engineering

Examination of recent amendments to the IEC 62366 standard for medical device usability engineering and how manufacturers are impacted. Learn more at Emergo by UL's Human Factors Research & Design (HFR&D) unit.
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  • Regulatory Update
Sep 22 , 2020

Japan PMD Act Revisions Include Fast-track Reviews for Some Medical Devices and IVDs

Fast-track Japan PMDA registration now open for qualifying medical device and IVD manufacturers as PMD Act revisions begin taking effect.
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  • Regulatory Update
Sep 15 , 2020

US FDA Updates Final Guidance on ISO 10993 for Medical Device Biocompatibility

Final FDA guidance on ISO 10993-1 for biological evaluation of medical devices gets an update. Learn more about US medical device regulations at Emergo by UL.
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  • Regulatory Update
Sep 3 , 2020

UK MHRA Issues New Guidance on UK REP and Medical Device Regulatory Compliance

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has posted new guidance regarding medical devices placed on the market in Great Britain
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  • Regulatory Update
Aug 19 , 2020

Updated European UDI FAQ Features Revised Compliance Deadlines

The European Commission has published a guide featuring complete timetables that incorporate recent regulatory postponements.
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  • Regulatory Update
Aug 18 , 2020

Understanding Sufficient Clinical Evidence Requirements Under the European Medical Devices Regulation

Considerations for medical device manufacturers ahead of MDR compliance for ensuring adequate clinical data management, including post-market clinical follow-up (PMCF) activities.
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  • Regulatory Update
Aug 11 , 2020

US FDA Medical Device User Fees Increase 7% for 2021

FDA user fees for the agency's 2021 fiscal year increase by seven percent, including for small-business applicants. Learn more about US FDA regulatory issues at Emergo by UL.
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