News

Expansion of Quality Management System certification scope for Health products (OMD).

Dear,

NCC has expanded its Quality Management System certification scope for Healthcare Products (OMD).

This time, NCC Certifications is accredited, as an (OMD), to carry out the In Vitro Diagnostic Medical Devices (IVD, or DIV in its acronym in Portuguese) certification by the ABNT NBR ISO 13485:2016 standard.

OMD is an accreditation by the Conformity Assessment Body to provide a consistent and reliable Quality Management System certification for Medical Devices, following ABNT NBR ISO 13485, in order to allow national authorities an opportunity to improve their Healthcare systems through the use of accredited certification (OMD) of manufacturing companies.

Certification (OMD) ensures that manufacturers consistently produce medical devices that meet regulatory requirements and are designed and manufactured to be safe for their intended use.