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
Year: 2019
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
FULL – Globiox’s office hours at The University of Texas Dell Medical School CoLab
All sessions are now FULL for Globiox’s office hours at the Texas Health CoLabs on August 15th and 16th, 2019. Check back in September for extended hours. Don’t forget – space is extremely limited and sessions are reserved quickly!
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
Latest Updates on Regulatory
Written by: Andrey Grishin, MD, Globiox Consultant With the recognition by the US Food and Drug Administration (FDA) of last country-member Slovakia just a few weeks ago, the European Union and the United States have now fully implemented the Mutual Recognition Agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective
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