ISO 14155 Update: Key risk management changes for medical device clinical investigations in 2019

Futuristic HexagonsThe third edition of the ISO 14155 standard for medical device clinical investigations is expected to be published in 2019. It could be published as early as this spring and probably arrive no later than mid-year.

According to the International Organization for Standards (ISO), the updated edition will focus on a more stringent risk management approach across all stages of clinical investigations from pivotal to Post-Market Clinical Follow-up (PMCF). Continue reading

Road Map of Real World Evidence (RWE) in Europe

Several European countries have been utilizing big data together with randomized control trials to guide healthcare decision making and to address market access issues. The Region Europe RWE Advisory Board was formulated to explore potential areas of real world evidence (RWE) use in countries like UK, France, Portugal etc. The board engages stakeholders including payers, providers, and patient organizations with the intent of developing a platform and widening the community for RWE. The board has developed a three-year road map of initiatives for the enhanced use of RWE. The contributors are spread across the areas of licensing, commissioning and access, clinical decision-making and patient outcome decision-making to prioritize four key action points.

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