Services Provided:

  • CE Marking of Medical Device
  • Installation & User Manual
  • Detailed Product Manufacturing Drawings

The Client:
For this project our Client was an established world leader in the healthcare industry. The company has had a presence in the Ireland for over 40 years. Our Client develops and supplies treatment solutions for complex medical conditions.

 

The Project:
The Product in this case was a cabinet enclosing an assembly of utility connections required for the operation of hemodialysis and reverse osmosis (RO) machines. The Product neatly houses all mains water, waste water drain and electrical connections required for the operation of these machines.


Project Engineering were hired to assist with the complex CE Marking process for Medical Devices.

Project Engineering identified the relevant European Directives, Classifications and Harmonised Standards. Working closely with the Client, Project Engineering prepared the essential CE Marking technical documentation, arranged the necessary electrical safety testing and constructed the Risk Management File.

One of the CE Marking requirements for Medical Devices is for comprehensive user/patient information to be provided with the product. Project Engineering prepared a comprehensive Installation and User Manual for the Product to meet the requirements set out in the CE Marking Directives and Standards.


Client Testimonial:

"Project Engineering were great on this project. The standard of documents and the thoroughness of their approach was excellent. The drawings and user manual were very clear, well laid-out and professional. Engaging Project Engineering allowed us to focus our resources on other aspects of the project and ultimately deliver the project on schedule.”