Seeking Expert Opinions and Volunteer Participation - Call for Nominations

NCCLS is seeking subcommittee membership for the following proposed project:

• Principles of Manufacturers’ Validation of Risk Mitigation Using Quality Controls

Manufacturers of in vitro diagnostic devices (IVDs) utilize risk management principles to develop, characterize, and improve their products. Various methods are used to mitigate risks that may be encountered when using the IVDs. One method is the use of internal or external quality controls. This proposed document will describe principles for validation of the effectiveness of quality controls for risk mitigation.

 Requested Expertise:

• Manufacturers who perform risk mitigation validation studies
• Government agency employees who review manufacturers’ data for clearance or approval
• Government or accreditation agency employees who can determine that the proposal meets accreditation requirements
• Laboratory employees who utilize quality controls for their IVD tests.

This proposed project is undergoing a progressive review process to assess the need and market potential for consensus document development.

Review the objective of the proposed project and the requested volunteer expertise, and:

Submit a nomination:
The deadline to submit the nomination form, including a curriculum vitae and disclosure of interests form, to the NCCLS Executive Offices is 10 December 2004.

Give us your expert opinion on the value of the project: 
To provide input on the need for, and utility of, this proposed new project, click here. [ return to top ]