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Training
The staff of VISAMED has a broad expertise in the medical device industry. VISAMED offers trainings on various subjects relating to, in the areas of regulatory, quality management, clinical trial management, and reimbursement.
VISAMED is providing the following training programs:
European Regulatory
 The CE Marking Process - European Medical Device Directives
Directive 2007/47/EC: Revisions to the Medical Device Directives
Quality Management System according to ISO 13485
Risk Management
Clinical Evaluation, Clinical Studies and Post-Market Clinical Studies
Risk Management File
Usability File
European Requirements for Software Contained in Medical Devices
European Medical Device Vigilance Requirements
Reimbursement Strategy
US Regulatory
510(k), IDE and PMA Submissions
Quality System Regulations (QSR) (US 21 CFR 820)
US FDA Medical Device Quality System Inspection: How to prepare?
Medical Device Reporting (MDR) requirements (US 21 CFR 803)
US Requirements for Software Contained in Medical Devices
Medical Device Corrections and Removals (US 21 CFR 806)
Canadian Regulatory
Canadian Medical Device Regulations
Quality System Requirements according to CAMCAS ISO 13485
Medical Device Reporting to Health Canada
VISAMED can customized training that will tailor your specific needs.
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Tel. +49(0)721-4764847