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Tag: IEC 60601-2-33
A safety and performance standard developed by the International Electrotechnical Commission (IEC) for magnetic resonance equipment used in medical imaging, ensuring reliability, safety, and compliance with global regulations.
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
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
General Safety & Performance Requirements — MR-scanner Related
Introduction to General Safety and Performance Requirements (GSPR) For anyone new to medical device trials, understanding General Safety and Performance Requirements (GSPR) is crucial. These requirements form the foundation of regulatory compliance under the European Medical Device Regulation (MDR) and Swissmedic’s / [or local responsible EU-CA] corresponding regulations. GSPR documents are essential in demonstrating that… Continue reading General Safety & Performance Requirements — MR-scanner Related
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
Demystifying the Investigator’s Brochure: A Comprehensive Guide to Preclinical Testing, Device Interactions, and Regulatory Compliance for Swissmedic and KEK Submissions
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