Cumulative risk of revision after primary total hip arthroplasty in registries: Systematic review and meta-analysis of selected hip stems and cups April 3, 2024 Read More »
CORE-MD Podcast – Alan Fraser & Per Kjaersgaard-Andersen – How do surgeons choose which Medical Device to implant? February 8, 2024 Read More »
CORE-MD Podcast – Alan Fraser & Berthold Koletzko – Providing Medical Devices for children January 25, 2024 Read More »
CORE-MD Podcast – Alan Fraser & Perla Marang-van de Mheen – Real-world evidence on the performance of High-Risk Medical Devices January 25, 2024 Read More »
CORE-MD Podcast – Alan Fraser & Richard Holborow – Understanding how EU Notified Bodies work January 25, 2024 Read More »
Focus on interventional cardiology: the need for quality and transparency of evidence for implantable cardiovascular medical devices January 15, 2024 Read More »
Quality and transparency of clinical evidence for high-risk cardiovascular medical devices: a long way to go November 30, 2023 Read More »
, Development of an AI-based IT tool to support medical device nomenclature standardization for postmarket surveillance by automated mapping from GMDN to EMDN standards November 17, 2023 Read More »
Development of a Framework Dealing with Partial Data Unavailability and Unstructuredness to Support Post-Market Surveillance November 17, 2023 Read More »
European cardiovascular registries as reliable data sources to assess implants safety and performances across the implant lifecycle. November 9, 2023 Read More »
Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature November 7, 2023 Read More »
An Integrative Systematic Review of Patient Reported Outcome Measures (PROMs) Used to Evaluate Orthopedic, Cardiovascular and Diabetes High Risk Implantable Medical Devices. September 4, 2023 Read More »
Clinical evidence of high-risk medical devices for diabetes management: A systematic review and meta-analysis September 4, 2023 Read More »
Placing patient-reported outcomes at the centre of cardiovascular clinical practice: implications for quality of care and management: August 23, 2023 Read More »
Post-approval evidence development schemes established by regulatory authorities for high-risk medical devices . August 1, 2023 Read More »
European expert recommendations on clinical investigation and evaluation of high-risk medical devices for children July 24, 2023 Read More »
Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review July 24, 2023 Read More »
Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives May 8, 2023 Read More »
Perceived training needs of regulators, notified bodies and clinicians for a (successful) implementation of the Medical Device Regulation: survey results April 17, 2023 Read More »
Achieving consensus on items needed to assess the quality and analysis of registry data for the regulatory evaluation of medical device performances during post-market surveillance: which items are the minimum requirements? March 15, 2023 Read More »
Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices’ PostMarket Surveillance January 15, 2023 Read More »
Clinical evidence for high-risk medical devices in children: A protocol for a scoping review December 31, 2022 Read More »
Orphan Medical Devices and Pediatric Cardiology – What Interventionists in Europe Need to Know, and What Needs to be Done October 18, 2022 Read More »
Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD Consortium September 4, 2022 Read More »
Study Design Recommendations in ISO Standards for High-risk Medical Devices, a Systematic Review of the Horizon2020 CORE-MD Project May 4, 2022 Read More »
Clinical evidence for high-risk medical devices in cardiology: a protocol for a systematic review and meta-epidemiological investigation February 11, 2022 Read More »
Study design recommendations in guidance documents for high-risk medical devices. A systematic review February 1, 2022 Read More »
Implementation of the new EU IVD Regulation – urgent initiatives are needed to avert impending crisis. January 12, 2022 Read More »
Development of an IT tool for assisting Medical Devices Post-Market Surveillance: application to the Italian scenario January 12, 2022 Read More »
Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices) October 19, 2021 Read More »
Orthopedic and cardiovascular medical device registries in Europe: a systematic review October 12, 2021 Read More »
Clinical investigations to evaluate high-risk orthopaedic devices: systematic review and meta-analysis September 29, 2021 Read More »
The need for transparency of clinical evidence for medical devices in Europe June 20, 2021 Read More »
Implementing the new European Regulations on medical devices—clinical responsibilities for evidence-based practice June 19, 2021 Read More »
Development of an IT tool for assisting Medical Devices Post-Market Surveillance: application to the Italian scenario January 12, 2022 Read More »
Cumulative risk of revision after primary total hip arthroplasty in registries: Systematic review and meta-analysis of selected hip stems and cups April 3, 2024 Read More »
Focus on interventional cardiology: the need for quality and transparency of evidence for implantable cardiovascular medical devices January 15, 2024 Read More »
Quality and transparency of clinical evidence for high-risk cardiovascular medical devices: a long way to go November 30, 2023 Read More »
, Development of an AI-based IT tool to support medical device nomenclature standardization for postmarket surveillance by automated mapping from GMDN to EMDN standards November 17, 2023 Read More »
Development of a Framework Dealing with Partial Data Unavailability and Unstructuredness to Support Post-Market Surveillance November 17, 2023 Read More »
European cardiovascular registries as reliable data sources to assess implants safety and performances across the implant lifecycle. November 9, 2023 Read More »
Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature November 7, 2023 Read More »
An Integrative Systematic Review of Patient Reported Outcome Measures (PROMs) Used to Evaluate Orthopedic, Cardiovascular and Diabetes High Risk Implantable Medical Devices. September 4, 2023 Read More »
Clinical evidence of high-risk medical devices for diabetes management: A systematic review and meta-analysis September 4, 2023 Read More »
Placing patient-reported outcomes at the centre of cardiovascular clinical practice: implications for quality of care and management: August 23, 2023 Read More »
Post-approval evidence development schemes established by regulatory authorities for high-risk medical devices . August 1, 2023 Read More »
European expert recommendations on clinical investigation and evaluation of high-risk medical devices for children July 24, 2023 Read More »
Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review July 24, 2023 Read More »
Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives May 8, 2023 Read More »
Perceived training needs of regulators, notified bodies and clinicians for a (successful) implementation of the Medical Device Regulation: survey results April 17, 2023 Read More »
Achieving consensus on items needed to assess the quality and analysis of registry data for the regulatory evaluation of medical device performances during post-market surveillance: which items are the minimum requirements? March 15, 2023 Read More »
Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices’ PostMarket Surveillance January 15, 2023 Read More »
Clinical evidence for high-risk medical devices in children: A protocol for a scoping review December 31, 2022 Read More »
Orphan Medical Devices and Pediatric Cardiology – What Interventionists in Europe Need to Know, and What Needs to be Done October 18, 2022 Read More »
Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD Consortium September 4, 2022 Read More »
Study Design Recommendations in ISO Standards for High-risk Medical Devices, a Systematic Review of the Horizon2020 CORE-MD Project May 4, 2022 Read More »
Clinical evidence for high-risk medical devices in cardiology: a protocol for a systematic review and meta-epidemiological investigation February 11, 2022 Read More »
Study design recommendations in guidance documents for high-risk medical devices. A systematic review February 1, 2022 Read More »
Implementation of the new EU IVD Regulation – urgent initiatives are needed to avert impending crisis. January 12, 2022 Read More »
Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices) October 19, 2021 Read More »
Orthopedic and cardiovascular medical device registries in Europe: a systematic review October 12, 2021 Read More »
Clinical investigations to evaluate high-risk orthopaedic devices: systematic review and meta-analysis September 29, 2021 Read More »
The need for transparency of clinical evidence for medical devices in Europe June 20, 2021 Read More »
Implementing the new European Regulations on medical devices—clinical responsibilities for evidence-based practice June 19, 2021 Read More »
CORE-MD Podcast – Alan Fraser & Per Kjaersgaard-Andersen – How do surgeons choose which Medical Device to implant? February 8, 2024 Read More »
CORE-MD Podcast – Alan Fraser & Berthold Koletzko – Providing Medical Devices for children January 25, 2024 Read More »
CORE-MD Podcast – Alan Fraser & Perla Marang-van de Mheen – Real-world evidence on the performance of High-Risk Medical Devices January 25, 2024 Read More »
CORE-MD Podcast – Alan Fraser & Richard Holborow – Understanding how EU Notified Bodies work January 25, 2024 Read More »
Development of an IT tool for assisting Medical Devices Post-Market Surveillance: application to the Italian scenario January 12, 2022 Read More »
