Basically, the Technical File comprises:
- A general description of the product;
- Sometimes a risk assessment to determine which safety and health requirements apply to the product;
- Design and production drawings;
- Detailed technical drawings about the essential aspects of the product;
- A list with the essential health and safety requirements that were met;
- Report of performed calculations and tests;
- Certificates and inspection reports;
- User’s manual;
- For series production, the internal stipulations that were complied with to guarantee conformity with the Directive(s)
With offices in the US, the Netherlands, Germany and China we offer tailored solutions for all complexities our clients encounter. We dedicate our services to improve the safety level for products of our clients and subsequently for a safer world for everyone.