Large manufacturer of pharmaceutical dispensing products.
Assessment of assembly and packaging line, consisting of machinery designed by the client but manufactured by external suppliers.
What we did:
- Detailed assessment of the design of all of the equipment in the line against applicable CE marking regulations and harmonised standards.
- Listed required content for Technical File and reviewed existing documentation in order to identify gaps in documentation.
- Identified non compliances and advised on modifications to mechanical and electrical design to achieve compliance.
What the customer did:
- Supplied us with detailed mechanical and electrical design drawings for assessment.
- Undertook the design of necessary modifications and collated the Technical File and most of the content.
The customer made the relevant modifications to the production line and updated their documentaion.