CE marking has a detailed set of requirements for technical documentation, which mainly depend on the type of product and the applicable European directives or regulations. The following are the main requirements that may be included in the CE certification technical file of the shortwave therapy device in general:
Product Description: Provide a detailed description of the shortwave therapy device, including the name, model, use, function and other basic information of the product.
Design and Manufacturing: Describe in detail the design and manufacturing process of the product, including the materials used, the process flow, the assembly process, etc.
Performance and Specifications: Provide the performance specifications of the product, including the technical characteristics, functions, performance parameters of the product, etc.
Risk Assessment: Conduct a risk assessment to identify and assess potential risks associated with the product and describe the controls in place.
Electromagnetic Compatibility: For electronic and electrical equipment, EMC test reports in accordance with European standards are provided.
Safety and performance testing: Provide safety and performance test reports for products to ensure that products comply with applicable European standards.
Clinical evaluation: For medical devices, a clinical evaluation is conducted to evaluate the safety and performance of the product.
Quality Management System: Provide documentation of the company's quality management system to ensure a consistent level of quality throughout the life cycle of the product.
Integrity of Technical Documentation: Ensure the integrity of technical documentation, including all necessary documentation, reports, certificates, etc.
Instructions for use: Provide clear and detailed instructions for use, including safe use of the product, maintenance requirements, etc.
CE Declaration: The manufacturer or his authorized representative is required to sign the CE Declaration, declaring that the product complies with the requirements of the applicable European directives or regulations.