Reference project

Safety test for IVD, laboratory or medical devices

A client (test laboratory) completes tests for the conformity of ophthalmological diagnostic devices to current test standards. They require support with the conformity assessment and completion of the test according to DIN EN ISO 60601, version 3, for previously launched systems compliant to older versions of the standard.


Based on our continuous support, we enabled our client to increase their capacities.

Thomas Wagner, Project Manager, Medical Technology Process Qualification, EXCO GmbH

Activities

Accomplishment and documentation of tests to prove the device safety:

  • Risk Evaluation
  • Evaluation of the user-friendliness
  • Usability
  • Visual examination for compliance documentation
  • Creation of testing records
  • Inspection reports
  • Test reports
  • Technical reports (CSA)
  • Check lists
  • Risk Analysis
  • Review of risk management documents (operation instructions, service manuals)

Implementation

EXCO completes the required electrical measurements of devices as well as the mechanical tests. EXCO records the measurement results on basis of standards assessment.


Client benefits
  • Independent interpretation of the standard requirements and evaluation of devices under test.
  • Relieving the department of its workload and increasing the capacities.

Client

Market-leading independent test laboratory, Germany

Expert contact

Stephan Blab

T+49 6233 73778-120