Staying Ahead: Navigating Timely Training and Version Control in Pharmaceuticals and Medical Devices

written by: Jenny Azarh In the dynamic world of Pharmaceuticals and Medical Devices, maintaining regulatory compliance and ensuring the highest standards of quality is crucial for ensuring patient safety. Throughout 2023, Globiox auditors conducted over 40 quality audits, revealing a recurring issue within the industry: overdue training and delayed training acknowledgments. This common challenge underscores

Event: Register Today for ‘Building a Medical Device Quality Management System with Limited Resources’

Make the most out of BioFest Days and join us for an enlightening session hosted by Globiox, where seasoned subject matter experts (SMEs) share their wealth of knowledge on implementing a Quality Management System (QMS) for the medical device industry.  🔍 What to Expect:  Panel Overview: Globiox SMEs will guide you through the intricacies of building

Globiox Stands Up and Stands Out at Biofest Invest

Globiox, a premier quality assurance firm, takes the stage as a presenting sponsor of Biofest Invest, reaffirming its commitment to innovation, growth, and collaboration within central Texas’ vibrant life sciences ecosystem.  San Antonio, TX – Globiox, a technical quality assurance consulting firm headquartered in Austin, Texas, announces its role as presenting sponsor for Biofest Invest,

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

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

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