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Overview
The service provider offers to conduct a comprehensive analysis of the product innovation in terms of the applicable provisions of the European Union law required to prepare the CE declaration of conformity required when introducing the product to the single market of the European Union. The service consists of identifying the NLF Directives and Regulations (including LVD, EMC, RED, Machinery, and RoHS) applicable to the assessed innovation and identifying the essential requirements resulting from them. The final product of the service is a detailed report with a compliance matrix (essential requirements vs. standardised technical requirements, including, e.g., applied harmonised standards) and a complete template of the declaration of conformity, ready for use by the manufacturer.
More about the service
• Reduced legal risk: identification and elimination of nonconformities before production or market launch.
• Shortened time to market: a clear path of action reduces unnecessary corrections and retesting.
• Cost optimisation: avoidance of financial penalties, delay costs, and costly design changes at a later stage.
• Process predictability: A transparent work schedule and a clear set of documents enable planning of the product implementation schedule.
• Comprehensiveness: service from documentation audit, through its analysis, to the development of a ready declaration of conformity.
• Shortened time to market: a clear path of action reduces unnecessary corrections and retesting.
• Cost optimisation: avoidance of financial penalties, delay costs, and costly design changes at a later stage.
• Process predictability: A transparent work schedule and a clear set of documents enable planning of the product implementation schedule.
• Comprehensiveness: service from documentation audit, through its analysis, to the development of a ready declaration of conformity.
The service will be delivered in the following steps and with outputs:
1) Preparation and kickoff
Collecting technical and legal documentation (specifications, algorithm descriptions, previous test results).
Defining the scope of work and schedule.
2) Matrix analysis
Mapping device functions to the requirements of EU directives (LVD, EMC, RED, Machinery, RoHS, etc.).
Defining harmonised standards to be applied if they exist
3) Gap report
Identification of formal inconsistencies
Prioritisation of areas for improvement.
4) Preparation of declaration of conformity
Comprehensive final report with a conformity matrix.
Preparation of a ready-to-use declaration of conformity template.
Form of provision: at premises of service provider, remotely, or on-site at the customer's location in any EU country.
Lead time: typically up to 4 weeks from delivery of full documentation (may be shortened for smaller scope or extended in the case of field tests of agricultural machinery)
1) Preparation and kickoff
Collecting technical and legal documentation (specifications, algorithm descriptions, previous test results).
Defining the scope of work and schedule.
2) Matrix analysis
Mapping device functions to the requirements of EU directives (LVD, EMC, RED, Machinery, RoHS, etc.).
Defining harmonised standards to be applied if they exist
3) Gap report
Identification of formal inconsistencies
Prioritisation of areas for improvement.
4) Preparation of declaration of conformity
Comprehensive final report with a conformity matrix.
Preparation of a ready-to-use declaration of conformity template.
Form of provision: at premises of service provider, remotely, or on-site at the customer's location in any EU country.
Lead time: typically up to 4 weeks from delivery of full documentation (may be shortened for smaller scope or extended in the case of field tests of agricultural machinery)
In order for the service to be properly performed, the client is obliged to provide full access to the data, documentation, proposals for standards, and other studies conducted for the needs of the innovation (device, technology, system) that is the subject of the service. A direct or remote conversation with the client will be required. We require photographs and a description of a fully functional prototype as well as complete technical documentation. All information is treated confidentially, with the option to sign a Non-Disclosure Agreement (NDA). Please be aware of the risk of prototype damage during endurance tests. If the tests need to comply with specific industry standards or regulations, kindly inform us in advance. The timeframe and costs are determined individually based on the scope and complexity of the device.
Location
At user's premises
Poland
Type of Sector
Arable farming
Food processing
Greenhouse
Horticulture
Livestock farming
Tree Crops
Viticulture
Type of service
Certification
Conformity assessment
Cybersecurity
ELSA assessment
Regulatory sandbox
Test design
Test setup
Accepted type of products
Design / Documentation
Physical system
Software or AI model
