Printing EnvisionTEC  NP Swabs

EnvisionTEC has been working closely with the Harvard Microbiology Lab within a larger group dedicated to connecting academia with the manufacturing industry to combat NP Swabs shortage. EnvisionTEC engineers have designed a collection tip for a flexible nasal swab made with EnvisionTec E-Guide Soft material, EnvisionTEC has worked with Beth Israel Deaconess Medical Center (BIDMC) of Boston’s Biomedical Laboratory, to obtain Institutional Review Board (IRB) approval.

An IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights, safety and welfare of human research subjects.

The NP Swabs provided to the IRB from EnvisionTec for approval were printed on the Envision One cDLM with E-Guide Soft material.

Other consideration.

• The NP Swab must be sterilized to be a finished product.
• Any lab producing the NP Swab must be registered with the FDA.
• The Swabs must be manufactured in compliance with FDA Tilte 21 CFR Part 820 QUALITY SYSTEM REGULATION

Contact EnvisionTec for complete approved process of printing the NP Swabs .

ENVISIONTEC, INC.

15162 S. Commerce Dr.

Dearborn, MI 48120, USA

https://envisiontec.com/

email covid19@envisiontec.com

Phone +1-313-436-4300