Insights
Industry Trends & Updates
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.
Healing Childhood Abuse Wounds
The trauma experienced in childhood can have lasting effects that can manifest in a variety of ways on a person’s mental wellbeing in adulthood.
Breaking the Taboo
A worrying trend observed across all regions and language groups is the global decline in the mental health and wellbeing of younger generations.
Innovation for Mental Wellness
Innovation for mental wellness tackles the problems caused by poor access to mental health care services that lead to significant public health issues.
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