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Description of Product
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Product name or trade name
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(X)
|
X
|
|
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General Description
|
X
|
X
|
|
|
Classification and justification
|
(X)
|
X
|
|
|
Variants / configurations
|
(X)
|
X
|
|
|
Photographies
|
X
|
X
|
|
|
|
|
|
|
Identification
|
UDI DI
|
-
|
X
|
|
|
|
|
|
|
Intended use
|
Intended use
|
X
|
X
|
|
|
Intended user
|
-
|
X
|
|
|
Patient population
|
-
|
X
|
|
|
Indication and contraindication
|
-
|
X
|
|
|
Intended use
|
(X)
|
X
|
|
|
Accessories
|
-
|
X
|
|
|
Interaction with other products
|
(X)
|
X
|
|
|
|
|
|
|
Physical principle
|
Description of the innovations
|
-
|
X
|
|
|
Overview of similar products
|
-
|
X
|
|
|
Overview of predecessor products
|
-
|
X
|
|
|
|
|
|
|
Structure
|
Essential functions
|
-
|
X
|
|
|
Parts, components, composition
|
X
|
X
|
|
|
Drawings, diagrams, explanations
|
X
|
X
|
|
|
Description of materials (for physical contact)
|
-
|
X
|
|
|
Technical specifications
|
-
|
X
|
|
|
Calculations
|
X
|
-
|
|
|
|
|
|
|
Labeling
|
Brochures, catalogues
|
-
|
X
|
|
|
Instructions for use
|
X
|
X
|
|
|
Labelling
|
X
|
X
|
|
|
Packaging
|
-
|
X
|
|
|
|
|
|
|
Production
|
Development and production phases including validation of process and tools, testing of the product
|
X
|
X
|
|
|
Details of all locations, including all suppliers and subcontractors involved in development and production
|
-
|
X
|
|
|
|
|
|
|
Quality assurance
|
Performance and safety requirements
|
X
|
X
|
|
|
References to evidence of all essential requirements
|
X
|
X
|
|
|
Verification and validation to prove the essential requirements with justification of the choice, in particular regarding safety, accuracy, interoperability
|
X
|
X
|
|
|
Mention of all harmonised standards or other standards
|
X
|
X
|
|
|
|
|
|
|
Risk management
|
Risk-benefit analysis
|
X
|
X
|
|
|
Risk management plan
|
X
|
X
|
|
|
Risk acceptance
|
X
|
X
|
|
|
Risk analysis (also through usability, production and downstream phase)
|
X
|
(X)
|
|
|
Measures to control the risk
|
(X)
|
X
|
|
|
Results of risk management and resulting measures
|
X
|
X
|
|
|
|
|
|
|
Data from research and development (pre-clinical and clinical data)
|
Results of preliminary tests (e.g. laboratory, simulation, animal experiments) including description of the test design
|
(X)
|
X
|
|
|
Clinical evaluation
|
X
|
X
|
|
|
|
|
|
|
Software
|
Validation
|
X
|
X
|
|
|
Verification
|
(X)
|
X
|
|
|
Architecture
|
_
|
X
|
|
|
Development process
|
X
|
X
|
|
|
Tests with different hardware
|
-
|
X
|
|
|
In-house tests and in an operating environment
|
-
|
X
|
|
|
|
|
|
|
Postproduction
|
|
-
|
X
|
Dipl.-Ing. (FH) Roland Gänßler