Insights
Industry Trends & Updates
inXso Joins SHIFT-HUB as an Official Partnership Organisation
inXso is delighted to announce our joining of an official partnership organisation with SHIFT-HUB, a pan-European Smart Health Innovation Hub.
Beyond the Brain: The Role of Gut Health in Autism Spectrum Disorder
Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition characterised by challenges in social interaction, communication, and repetitive behaviours.
International Reimbursement Strategy for Orthopaedic Therapy Device
Leverage inXso’s expertise to create a successful reimbursement strategy and identify optimal countries regarding market introduction and revenue realisation.
Clinical Evaluation & Investigation of Active Therapeutic Device
Case study to transit an active therapeutic device from the preclinical to the clinical phase using clinical design, development and regulatory considerations.
Conquering Cancer: Insights and Innovations from World Cancer Day 2024
Despite the surge of scientific and technological advancements in cancer prevention, diagnosis and treatment, cancer is the leading cause of death worldwide.
FDA Transition to ISO 13485: Regulatory Impact
The FDA transition to ISO 13485 is a significant step in streamlining medical device manufacturers’ quality management systems for international operations.
Internationalisation Services for EIC Beneficiaries in the Healthcare Sector
Internationalisation services for EIC beneficiaries in the healthcare sector are provided by inXso in the framework of the EIC Ecosystem Partnership.
Sponsors and Legal Representatives – Clinical Evaluation & Investigation under EU MDR 2017/745
The EU MDR 2017/745 regulation introduced a set of requirements for conducting clinical trials of medical devices and their sponsors and legal representatives.
FDA Regulatory Reform Outlook 2023
FDA Regulatory Reform Outlook 2023 focuses on the significant changes to the FDA regulatory framework and several initiatives that are waiting on the horizon.
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