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Home
Consulting
Technical Documentation
Software (IEC 62304, FDA)
Risk Management (ISO 14971)
Usability (IEC 62366, FDA HFE)
Clinical Evaluation
Quality Management (QM)
QM System (ISO 13485)
Mock Audits & Inspections
Quality Representative
E-Learning
Training videos
Market your medical device
Content
Premium Version
Watch training videos
Training Seminars
Medical Device Regulation
CPMS Seminar
Medical Device Software
Human Factors Engineering
Risk Management Seminar
Inhouse Seminars
Articles
Regulatory Affairs
Medical Device Regulation
IVD Regulation (IVDR)
Medical Device Directive
Classification
CE Marking
Conformity Assessment
Harmonized Standards
And more ...
QM System & ISO 13485
ISO 13485:2016
Audits
MDSAP
Unannounced Audit
CSV
Software & IEC 62304
Software Lifecycle
Safety Classes & Level of Concern
SOUP and OTS
Medical Apps
IT-Security
Risk Management & ISO 14971
Life Cycle Risk Management
Update 14971:2012
Harm and Severity
Hazard and Hazardous Situation
Risk Acceptance
Risk Mitigation
Risk Analysis
Software Specifics
Usability & IEC 62366
Main Operating Functions
ISO 9241
User stories
Usability Validation
Product Development
Intended Use Description
System Architecture
Verification versus Validation
Clinical Evaluation
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