UK Flag

MHRA Announces New UK Approved Bodies

By MedTech Intelligence Staff

The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, LNE-GMED UK and Scarlet NB UK. They join the seven current UK Approved Bodies, increasing…

The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, LNE-GMED UK and Scarlet NB UK. They join the seven current UK Approved Bodies, increasing…

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Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

By Celegence

Download this case study for insights on optimized regulatory processes via tech-enabled services from Celegence. Acumed made their MDR compliance a success by boosting efficiency, saving time, and streamlining collaboration….

Download this case study for insights on optimized regulatory processes via tech-enabled services from Celegence. Acumed made their MDR compliance a success by boosting efficiency, saving time, and streamlining collaboration….

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Clinical Evaluation

Role of Clinical Evaluation Report Consultants

By Anushree Singh

…brought forth by the EU MDR, sometimes utilizing advanced AI-enabled technology and related resources that can provide MDR compliant CEP/CER’s quickly. Related consulting services may also include medical writing capabilities,…

…brought forth by the EU MDR, sometimes utilizing advanced AI-enabled technology and related resources that can provide MDR compliant CEP/CER’s quickly. Related consulting services may also include medical writing capabilities,…

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European Union Flag

European Commission Proposes Extension for EU IVDR Compliance

By MedTech Intelligence Staff

On January 23, the European Commission put forth a proposal that would extend the deadline for compliance with EU In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. The…

On January 23, the European Commission put forth a proposal that would extend the deadline for compliance with EU In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. The…

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510k Submission Planning

510k Submission Planning

By Joy Greidanus

…be considered as test plans are developed to avoid retesting. In addition, creating the Clinical Evaluation Report required by the EU MDR early on can assist in educating the team…

…be considered as test plans are developed to avoid retesting. In addition, creating the Clinical Evaluation Report required by the EU MDR early on can assist in educating the team…

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Microphone

Call for Abstracts: MTI Regulatory Intelligence and Networking Summit

By MedTech Intelligence Staff

…MedTech regulatory process and compliance. Session and workshops during the 3-day Summit deliver insights addressing a breadth of content—from the ever-changing global landscape of MDR requirements to the latest guidance…

…MedTech regulatory process and compliance. Session and workshops during the 3-day Summit deliver insights addressing a breadth of content—from the ever-changing global landscape of MDR requirements to the latest guidance…

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The ultimate guide to the EU MDR and IVDR GSPR, 2nd Edition

The ultimate guide to the EU MDR and IVDR GSPR, 2nd Edition

By Rimsys

…and performance requirements for both the EU MDR and IVDR and includes tables comparing the EU MDD and IVDD Essential Principles with MDR and IVDR General Safety and Performance Requirements….

…and performance requirements for both the EU MDR and IVDR and includes tables comparing the EU MDD and IVDD Essential Principles with MDR and IVDR General Safety and Performance Requirements….

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Dhaval Shah
MEDdesign

Navigating Global Regulations for SaMD

By Dhaval Shah

…harmonizing ML best practices to better evaluate and improve ML algorithms, drive device transparency, support regulatory sciences and advance real-world performance monitoring measures. EU Regulations The EU Medical Device Regulation…

…harmonizing ML best practices to better evaluate and improve ML algorithms, drive device transparency, support regulatory sciences and advance real-world performance monitoring measures. EU Regulations The EU Medical Device Regulation…

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Karandeep Badwal

Preparing for EU MDR Post Market Reporting

By MedTech Intelligence Staff

…discusses the change in focus from EU MDD to EU MDR, and how companies will need to adapt to meet new reporting requirements and maintain compliance in the European market….

…discusses the change in focus from EU MDD to EU MDR, and how companies will need to adapt to meet new reporting requirements and maintain compliance in the European market….

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