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Tag: ISO 14155
An international standard for the design, conduct, and documentation of clinical investigations involving medical devices to ensure safety and scientific validity.
General Safety & Performance Requirements — Risk Analyses Overall System of Trial
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Research on Investigational Medical Devices in Switzerland: Legal Insights and EU-MDR Context
Switzerland’s regulatory framework for clinical investigations with medical devices, including investigational devices like experimental MR-pulse sequences and non-CE-marked RF coils, is governed by the Ordinance on Clinical Trials with Medical Devices (ClinO-MD). This aligns with the Swiss Human Research Act (HRA) and is influenced by the European Union’s Medical Device Regulation (EU-MDR) to ensure harmonized… Continue reading Research on Investigational Medical Devices in Switzerland: Legal Insights and EU-MDR Context
Ethics proposal — The Clinical Investigation Plan (CIP)
Introduction Navigating the bureaucracy behind clinical trials in Switzerland is no small feat. As a researcher preparing the SIGNATURES2023 study, I quickly found that working with both the local Cantonal Ethics Commission (CEC) and Swissmedic / EMA — two independent bodies with their own rules and regulations — requires a level of coordination and compliance that… Continue reading Ethics proposal — The Clinical Investigation Plan (CIP)
Lead EC: General and main site’s documents
Essential BASEC Documents for Ultra-High Field MR Projects Discover the key documents required for submitting an in vivo MR project to BASEC/your local EU-CA/[your local EU-CA/ethics committee], focusing on investigations using non-CE-marked RF coils and pulse sequences, not necessarily, at ultra-high field strengths. In the Table below you find all the documents uploaded to BASEC… Continue reading Lead EC: General and main site’s documents
Case Report Forms (CRFs)
Introduction Case Report Forms (CRFs) are standardized documents used to systematically collect and record data during clinical investigations, ensuring consistency, accuracy, and completeness in documenting research outcomes. They are critical for capturing patient demographics, medical history, investigational procedures, adverse events, and study outcomes in alignment with the study protocol. CRFs are required by regulatory bodies,… Continue reading Case Report Forms (CRFs)
Risk Analysis in MR Medical Device Trials
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Developing a Risk Management Plan for MR Medical Device Trials
Introduction A Risk Management Plan is a critical document required in medical device projects, ensuring compliance with internationally recognized standards such as ISO 14971 (“Medical Devices – Application of Risk Management to Medical Devices”). This standard provides a structured framework for identifying, evaluating, mitigating, and monitoring risks throughout the lifecycle of a medical device, safeguarding… Continue reading Developing a Risk Management Plan for MR Medical Device Trials
Developing a Risk Management Report for MR Medical Device Trials
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How to Apply for an Ethics Approval for your MR-research
🇨🇭 How to Apply for an Ethics Approval for Your MR-Research Navigating the ethics approval process for your MR research can be a daunting task, particularly when investigator-initiated trials (IIT) and strict legal compliance are involved. Even after securing funding from organizations like the Swiss National Science Foundation (SNSF) or the EU Commission, the real… Continue reading How to Apply for an Ethics Approval for your MR-research
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