To support the smooth market placement of a robot-based test system, EXCO's CE Conformity Assessment team was asked to provide support. The team ensured that all legal requirements of the Machinery Directive were met and that the test robot could be operated properly.
Tasks
The requirements of the Machinery Directive 2006/42/EC impose a high level of safety for machinery placed on the market. These requirements include, among other things, the performance of an EU conformity assessment procedure. Upon successful completion of the procedure, the machine must bear the CE marking to indicate conformity with the applicable EU regulations.
Implementation in detail
- Consulting during development on legally required safety and regulatory requirements
- Review of component documentation provided with the product
- Development of safety requirements and solutions for safe operation
- Consulting on required product safety testing
- Gap analysis of the technical documentation
- Support for and preparation of the risk assessment
- Preparation of the instructions for use in accordance with applicable standards
- Support for and preparation of the product documentation
- Compilation of the technical documentation / conformity assessment file
"Mit EXCO haben Kunden einen zuverlässigen Partner bei der Entwicklung neuer Produkte bis hin zur späteren Zulassung und Inverkerbringung nach den gültigen nationalen und internationalen gesetzlichen Vorgaben."
Client benefits
- Enhanced product safety
- Safe operation for end users
- Compliance with applicable legal requirements
Client
Medical Device Manufacturer
