September Office Hours At The University of Texas Dell Medical School CoLab

We are now offering office hours at The University of Texas Health CoLab to meet with aspiring life science companies for 1 hour consultations (FREE) 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

Challenges of the Medical Device Market for New Manufacturers

Written by: Andrey Grishin, MD, Globiox Consultant Ensuring Quality of the Final Product. Every Medical device manufacturer must guaranty high product quality to avoid costly product recalls and legal issues which can also pose risk to the public. Product recall negatively impacts its brand reputation and the company’s bottom line. Ensuring required product safety, security

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

Combined use diagnostic instruments and the FDA’s thoughts

The FDA has recently released a draft guidance entitled “Molecular Diagnostic Instruments with Combined Functions.” The recommendations display intent to mitigate interference in molecular diagnostic instruments with combined FDA approved device functions and functions in which FDA approval is not required, and furthermore prevent confusion for the end user. While following the guideline should serve

What happens when you can’t test a test?

Test Method Validation (TMV) is a critical part of ensuring quality for manufacturing. This highly specific aspect of validation involves proving that quality testing procedures for a manufacturing process consistently provide accurate results. When a TMV fails, specific steps must be taken, in the proper order, to ensure the best remediation and damage control possible.