Globiox’s Office Hours at The University of Texas Health CoLab

Globiox is excited to announce office hours at The University of Texas Health CoLab to meet with aspiring life science companies for 1 hour consultations regarding Quality Management Systems, GxP Audits, Regulatory Strategy, Operations Support, Information Technology, Computer System Validation, Equipment Qualification, Facilities Qualification, and Clinical Services. ***Reservations are made through the dellmed.utexas.edu website (provided

Clinical Evaluation Reports (CER) –

Written by: Daniel Miranda, Globiox Consultant Clinical evaluation is a critical, ongoing task that must be performed by medical device manufacturers who market products in the European Union and seek to obtain or maintain a CE mark. This task is completed via creation of a clinical evaluation report (CER). A CER must be created prior

Almost There: Safety and Performance Pathway Option for 510(k) Submissions

Written by: Daniel Miranda, Globiox Consultant On 1/22/2019, the FDA posted their final guidance describing the Safety and Performance Pathway option for 510(k) submissions. This pathway gives another option for medical devices that have technological differences but that are still as safe and effective as a legally marketed predicate device. Typically, in these situations, the

The FDA’s “dos” and “don’ts” for responding to a 483

DO! • Include photos where possible. • Include documentation to provide evidence that corrective actions have been implemented. • Pay particular attention to observations that are noted as being repeated from previous inspections. If you have not remediated a previous observation, it may be that you did not understand what the FDA meant. Ask!  If