ISE Europe GmbH produces technical documentation, analyzes global regulatory requirements for devices, and advises on product development and compliance evaluations for Europe and the United States. The company also provides services including risk assessment, support for the Chinese market, technical communication, terminology, user experience lifecycle and system-solution development, and distributes fieldwork software in Europe.
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Preparation of technical documentation for devices and products, including supporting materials for development, evaluation and regulatory requirements.
Regulatory consulting and compliance assessment
Research of global regulatory requirements for devices, assessment of target products and compliance assessments in Europe and the United States.
Product development consulting
Consulting for developing the specified products and devices, focusing on technical requirements, evaluation and implementation.
Fieldwork services and consulting
Implementation and consulting around fieldwork, as well as specialised fieldwork software in Europe.
Risk assessment
Risk assessment in the context of technical documentation, product assessment and regulatory compliance.
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